Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. An Open-Label Long-Term Naturalistic Study of Mirtazapine Treatment for Depression in Cancer Patients An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. Mirtazapine improves sleep and lowers anxiety and depression in cancer patients: superiority over imipramine Mirtazapine for the treatment of hot flushes in breast cancer survivors: a prospective pilot trial. Phase II Trial of Mirtazapine for Cancer-Related Cachexia and Anorexia Efficacy and tolerability of mirtazapine in treating major depressive disorder with anxiety symptoms: an 8-week open-label randomised paroxetine-controlled trial. The Use of Antidepressants for Physical and Psychological Symptoms in Cancer. A multicentre, double-blind, amitriptyline-controlled study of mirtazapine in patients with major depression Add-on mirtazapine enhances antipsychotic effect of first generation antipsychotics in schizophrenia: A double-blind, randomized, placebo-controlled trial Efficacy of mirtazapine for prevention of depressive relapse: a placebo-controlled double-blind trial of recently remitted high-risk patients. Low-Dose Mirtazapine: A New Option in the Treatment of Antipsychotic-Induced Akathisia. A Randomized, Double-Blind, Placebo- and Propranolol-Controlled Trial Efficacy and tolerability of mirtazapine versus citalopram: a double-blind, randomized study in patients with major depressive disorder. Nordic Antidepressant Study Group. Mirtazapine vs. amitriptyline vs. placebo in the treatment of major depressive disorder. A pilot study to evaluate symptom-oriented selection of antidepressants in patients with cancer. Mirtazapine versus amitriptyline in the long‐term treatment of depression: a double‐blind placebo‐controlled study Mirtazapine compared with paroxetine in major depression.
AIMS The purpose of the present paper was to evaluate the effectiveness of mirtazapine orally disintegrating tablets for nausea and sleep disturbance , which are common and distressing symptoms of cancer . METHODS This was a 4-week , prospect i ve , open-labeled study of cancer patients . Assessment s were performed at baseline and on days 1 , 3 , 5 , 7 , 14 , and 28 . Primary outcome measures were the Clinical Global Impression scale for nausea/vomiting and the Chonnam National University Hospital-Leeds Sleep Evaluation Question naire ( C-LSEQ ) including total amount of night sleep time . The secondary outcome measures consisted of pain items in the 36-item Short Form Health Survey , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the EuroQoL (EQ)-5D .  Forty-two cancer patients were enrolled . RESULTS Those with nausea ( n = 28 ) improved significantly from day 1 . The total night sleep time and each item on the C-LSEQ improved from days 1 - 5 . The scores on the MADRS and the depression/anxiety dimension and visual analog scale of EQ-5D improved significantly from the first week . Pain measures also improved from day 1 . Exacerbation of sleepiness developed in approximately one-third of subjects during the initial few days , but disappeared gradually . CONCLUSION In the present study mirtazapine rapidly improved nausea , sleep disturbance , pain and quality of life , as well as depression in cancer patients .  Mirtazapine may be an effective treatment option in managing cancer patients with multiple distressing symptoms , including nausea and sleep disturbance Abstract Background : Depression is quite common among cancer patients . It has yet to be determined which antidepressant is the most effective in cancer patients with depression . Methods : The present study included 21 consecutive depressed oncology patients of whom 19 were followed up for 6 months . All patients initially received mirtazapine 15 mg/day and the dose was increased in the absence of significant treatment response and adverse effects . Results : Depressive symptoms diminished at the end of month 1 and this improvement was maintained for the remaining 23 weeks of the study . Mean 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) scores fell significantly from 21.4 ± 4.9 at baseline to 6.5 ± 3.2 at the end of the first month of treatment ( p < 0.001 ) . Among the 19 patients who were followed up , five reported at least one adverse effect during treatment ; however , the vast majority of these adverse effects were described as mild to moderate . Conclusion : This prospect i ve , open-label study provides preliminary evidence regarding the efficacy , safety and tolerability  of mirtazapine treatment in cancer patients with depression . Relatively low doses of mirtazapine appeared to be safe and effective for treating cancer patients undergoing radiotherapy and /or chemotherapy , and the reduction in the severity of depressive symptoms was maintained until the end of the 24-week treatment period We performed a pilot open-label , crossover trial of mirtazapine ( 15 and 30 mg at night ) in advanced cancer patients with pain and other distressing symptoms . Twenty patients completed the trial and sixteen dropped out . Following a baseline assessment , patients completed a one-week observation period and were then r and omized to a starting dose of either 15 mg or 30 mg of mirtazapine given at bedtime . After three weeks , subjects were switched to the alternate dose and followed by an additional three-week period , completing the treatment . The average age of the completers was 60.2 years and consisted of 7 women and 13 men . The majority were Caucasian ( n = 18 , 90 % ) and married ( n = 18 , 90 % ) . The drop-out group did not significantly differ from the completers based on age , gender , race , marital status , or tumor type . We examined the impact of mirtazapine therapy on patients ' levels of depression , pain intensity , appetite , insomnia , weight , and overall quality of life . A series of repeated measures ANOVAs were conducted to compare the completers ' status at Weeks 1 , 4 , and 7 compared to baseline and to examine the interaction with starting dose and baseline observations . Scores on the Zung self-rating Depression Scale ( F = 8.20 , P < 0.05 ) and the Functional Assessment of Cancer Therapy - General Measure ( F = 5.73 , P < 0.05 ) were significantly improved at study end ( Week 7 ) and were not dependent on mirtazapine dosage . Patients ' weights were significantly higher at both Week 4 and Week 7 , independent of dosage . Trend level differences were found on Memorial Pain Assessment Card items for pain , pain relief , and mood and on numeric rating scales measuring nausea , anxiety , insomnia , and appetite . This open-label pilot study suggests that mirtazapine may be effective for improving multiple symptoms , depression and quality of life in patients with advanced cancer . A controlled trial of this drug would be valuable Goals of the workThis study aim ed to compare the effectiveness of mirtazapine and imipramine on not only the distressing symptoms of cancer patients such as pain , nausea , vomiting , appetite loss , and sleep disturbances  but also depressive and anxiety symptoms .  Material s and methods Fifty-three patients with cancer who were diagnosed with major depressive disorder , anxiety disorder , or adjustment disorder were included . Twenty patients on mirtazapine , 13 patients on imipramine , and 20 patients in the control group without medication were interviewed during three visits ( baseline , third week , and sixth week ) . Pain , nausea , vomiting , appetite loss , and sleep disturbances were evaluated with self- assessment single-symptom scales during each visit . The patients were also asked to complete the Hospital Anxiety Depression Scale ( HADS ) during each visit . Main results There were no significant differences among the three visits in the mirtazapine , imipramine , or control groups in terms of pain , nausea , vomiting , or appetite loss . For the initial , middle , and late insomnia , only the mirtazapine group showed improvements ( p = 0.001 , p = 0.001 , p = 0.003 ) . There were also significant differences in the mean total ( p = 0.03 ) , anxiety ( p = 0.003 ) , and depression ( p = 0.025 ) scores of HADS among the three visits for patients taking mirtazapine . There were no significant differences for HADS scores from the baseline to the end point for patients taking imipramine or control group patients . Conclusion Our findings suggest that mirtazapine is effective for resolving insomnia as well as anxiety and depressive symptoms in cancer patients . However , more systematic research , such as placebo-controlled studies , is needed The purpose s of the study are to evaluate the efficacy and safety of mirtazapine 30 mg/daily for 12 weeks to reduce hot flushes ( HF )  in women with previous breast cancer and to assess the influence of the same treatment on sleep quality and other menopausal symptoms . A prospect i ve pilot trial was conducted in 40 breast cancer patients with at least seven HF per day . A HF diary was completed daily ; sleep quality and other menopausal symptoms were assessed with the Pittsburgh Sleep Quality Index ( PSQI ) , the Menopause Rating Scale ( MRS ) and the SF-36 Health Survey . Treatment was never started by 13 out of 40 patients ( 32.5 % ) and was interrupted by 7 out of 27 patients ( 25 % ) due to of the occurrence of side effects ( mostly somnolence ) . In the remaining 20 patients who completed the three months treatment period , there was a 55.6 % ( p < 0.05 ) reduction in HF frequency and 61.9 % ( p < 0.05 ) reduction in HF score as compared to baseline . A significant reduction in the MRS score ( 32.8 % ; p < 0.05 ) was observed . Mirtazapine appears to be effective in reducing HF in breast cancer survivors . The more frequent side effect was somnolence . A sizeable compiliance problem has been observed due to the reluctance to take antidepressant drugs and to side effects We performed an open-label single-institution phase II trial of mirtazapine ( 15 - 30 mg by mouth [ po ] every day [ qd ] ) , a tetracyclic antidepressant that may lead to weight gain , for 8 weeks in nondepressed patients with cancer-related cachexia/anorexia ( CRCA ) . The primary end point was the proportion of patients who gained ≥1 kg at week 4 . Secondary end points were quality of life and appetite . From June 2006 to July 2007 , 17 of 58 eligible patients were enrolled . On intention-to-treat analysis at week 4 , 4 of 17 patients ( 24 % ) gained 1 kg or more , 1 patient maintained weight ( gain of 400 g ) and 2 patients lost weight ( 800 g and 1.2 kg ) ; 24 % and 6 % improved appetite and health-related quality of life ( HQOL ) , respectively . Mirtazapine is a promising agent for the treatment of CRCA AIMS Prominent anxiety symptoms are related to poor clinical course and outcome in major depressive disorder ( MDD ) . The aim of this r and omised , open-label , controlled study is to compare the efficacy and tolerability of mirtazapine in the form of orally disintegrating tablets against paroxetine in treating MDD patients with anxiety symptoms . METHODS A total of 60 MDD patients with a score above 18 on the Hamilton Anxiety Rating Scale ( HARS ) were r and omly assigned to 8 weeks of fixed dosing treatment with mirtazapine ( 15 - 30 mg/day ) and paroxetine ( 10 - 20 mg/day ) . Efficacy was primarily assessed with the HARS and with the 17-item Hamilton Depression Rating Scale ( HDRS ) at weeks 1 , 2 , 4 and 8 after treatment . Tolerability was assessed from adverse events . RESULTS The generalised estimating equations ( GEE ) models showed that the rates of improvement in HDRS scores from baseline to week 8 were similar between mirtazapine and paroxetine groups . However , patients with mirtazapine exhibited earlier improvement in HARS scores at weeks 1 and 2 . Week-by-week GEE models showed that these significant differences in improvement of HARS scores between the two treatment groups were detectable from the first evaluation after the treatment ( week 1 ) and maintained through week 2 . There was no difference in the overall frequency of adverse events experienced between the two treatment groups . The most common adverse event in the mirtazapine group was somnolence ( n = 8) , whereas that in the paroxetine group was gastrointestinal discomfort ( n = 9 ) . CONCLUSIONS Mirtazapine and paroxetine were equally effective and well tolerated for the depressive symptoms in MDD patients with the high level of anxiety symptoms .  Mirtazapine was , however , more effective in reducing the anxiety symptoms than paroxetine in the early weeks of treatment , suggesting that mirtazapine may have an earlier-onset action for the anxiety symptoms in MDD patients Cancer patients are commonly associated with various physical and psychological symptoms . In palliative setting , the aims are to relieve those symptoms , improve quality of life , and increase medication adherence among cancer patients . Antidepressants are generally accepted for the treatment of depression among patients with or without cancer . Some other potential benefits of the antidepressants have been reported in cancer patients . OBJECTIVE This study aims to review the use of antidepressants for physical and psychological symptoms in cancer patients . RESULTS Our findings showed the mixed result of positive and negative findings in various symptoms associated with cancer patients . These studies are categorised according to the hierarchy of evidence from high to low level , namely r and omised controlled trials , cohort studies , case-control studies , case series , case reports , as well as other type of publications . The majority of antidepressants used in cancer patients seem to be beneficial for the treatment of depression , anxiety , hot flashes and other symptoms such as sexual dysfunction , fatigue , nicotine dependence , vasomotor symptoms , executive functions , sleep problems , pruritus , as well as for hypochondriasis . While fluoxetine was found to be associated with the reduction of antiemetic property in ondansetron , mirtazapine was identified to be a good alternative in treating nausea and cachexia among cancer patients . CONCLUSION More research studies with adequate statistical power are warranted to vali date the use of antidepressants among cancer patients in treating these physical and psychological symptoms Background : the efficacy and tolerability of the new antidepressant mirtazapine were evaluated in a multicentre , r and omized , double-blind , amitriptyline-controlled , 5 week clinical study . Method : 156 patients with a DSM-III diagnosis of major depressive episode and 21-item Hamilton Psychiatric Rating Scale for Depression ( HPRSD ) score ≥ 18 , were r and omized to treatment with either mirtazapine  20 - 60 mg/day or amitriptyline  75 - 225 mg/day . Results : mirtazapine and amitriptyline were equally effective in reducing depressive symptoms , as assessed by the 17-item HPRSD and MADRS scales . Mirtazapine was better tolerated than amitriptyline , with fewer drop-outs due to adverse events and lower incidences of adverse events both at the beginning and at the end of the trial . Conclusion : this study shows that mirtazapine is as effective as amitriptyline in treating major depression , while at the same time better tolerated BACKGROUND Mirtazapine , an antidepressant with a broad spectrum of receptor affinity may , if combined with first generation antipsyhotics ( FGAs ) , improve clinical profile of the FGAs . However , potentiation of the antipsychotic effect by mirtazapine has not been reported thus far . We explored the efficacy of adjunctive mirtazapine on symptoms of schizophrenia in patients having an insufficient response to different FGAs . METHODS Schizophrenia-diagnosed patients with a prolonged disease and a history of a poor response to numerous antipsychotics , who were at least moderately ill despite their FGAs treatment , received add-on mirtazapine ( n=20 ) or placebo  ( n=19 ) in a 6-week double-blind r and omized controlled trial ( RCT ) . The analysis was made on a Modified Intent-to-Treat ( MITT ) basis with Last Observations Carried Forward ( LOCF ) . RESULTS Mirtazapine outranged placebo on almost all measures . The clear-cut clinical relevance of this finding was demonstrated by a large effect size of 1.00 ( 95 % CI 0.23 - 1.67 , p=0.003 ) on the total Positive and Negative Syndrome Scale ( PANSS ) scores ( the primary outcome ) . The PANSS positive subscale scores decreased by 17.2 % with mirtazapine vs. 1.6 % with placebo ( p<0.001 ) , and the PANSS negative subscale scores by 12 % and 3 % ( p<0.001 ) , correspondingly . CONCLUSIONS This is the first RCT reporting a robust additive antipsychotic effect of an adjunctive antidepressant . Mirtazapine-FGAs combination appears to be a safe , well-tolerated and efficacious treatment option in this challenging population . These findings are important due to the current re-emerging attention to FGAs . The focus of further studies should be exp and ed to include combinations with or switching to novel antipsychotics , different sub population s of patients with schizophrenia , finding of optimal doses , and comparison with clozapine BACKGROUND The necessity of antidepressant continuation-phase therapy following acute-phase response has result ed in the need to characterize the longer-term efficacy and safety of all new medications . Previous studies using " extension " protocol s suggest that mirtazapine has sustained antidepressant effects . The current study was performed to evaluate the efficacy and safety of up to 1 year of mirtazapine therapy , using a more rigorous , r and omized , placebo-controlled discontinuation design . METHOD An intent-to-treat sample of 410 patients meeting DSM-IV criteria for moderate-to-severe recurrent or chronic major depressive episodes began 8 to 12 weeks of open-label therapy with mirtazapine ( flexibly titrated , 15 - 45 mg/day ) . Thereafter , 156 fully remitted patients ( according to Hamilton Rating Scale for Depression and Clinical Global Impressions-Improvement scores ) were r and omly assigned to receive 40 weeks of double-blind continuation-phase therapy with either mirtazapine or placebo . RESULTS Mirtazapine therapy reduced the rate of depressive relapse by more than half , with 43.8 % of patients relapsing on treatment with placebo as compared with 19.7 % of the mirtazapine-treated patients . The discontinuation rate due to adverse events was 11.8 % for active mirtazapine therapy versus 2.5 % for placebo . Although weight gain was significantly greater in the group receiving active medication during the double-blind phase ( p = .001 ) , patients taking mirtazapine gained only 1.4 kg ( 3.1 lb ) across the 40 weeks of continuation therapy , and there was no difference in the rates of weight gain as a newonset adverse event . CONCLUSION Continuation-phase therapy with mirtazapine is effective and well tolerated BACKGROUND Preliminary evidence indicates a beneficial effect of serotonin 2A ( 5-HT(2A ) ) receptor antagonists in antipsychotic-induced akathisia ( AIA ) . We investigated the antiakathisia effect , safety , and tolerability of low-dose mirtazapine , an agent with marked 5-HT(2A ) antagonism . METHODS In a 7-day double-blind trial , 90 antipsychotic-treated patients meeting DSM-IV criteria for AIA were r and omly assigned to mirtazapine ( n = 30 ; 15 mg ) , propranolol ( n = 30 ; 80 mg ) , or placebo ( n = 30 ) . Primary outcome measures were between-group differences in Barnes Akathisia Scale ( BAS ) global scores and in the proportion of responders ( reduction of > or = 2 points on BAS ) . Analysis was by intention to treat . RESULTS Twenty-four patients ( 26.6 % ) who were assigned treatment did not complete the study ( 7 mirtazapine , 8 propranolol , 9 placebo ) , due to lack of response ( n = 19 ) and adverse events ( n = 5 ) . Both mirtazapine and propranolol significantly reduced AIA severity ( BAS : -34 % mirtazapine and -29 % propranolol vs. placebo -11 % ; p = .012 and p = .023 , respectively ) . Thirteen ( 43.3 % ) mirtazapine and 9 ( 30.0 % ) propranolol-treated patients versus 2 ( 6.7 % ) placebo-treated patients responded ( the corresponding odds ratios 10.7 [ 95 % confidence interval ( CI ) , 2.1 - 53.3 ] and 6.0 [ 95 % CI , 1.1 - 30.7 ] ) . Five ( 16.7 % ) of 30 propranolol-treated patients and none in the mirtazapine and placebo groups ( p = .0195 for both ) prematurely discontinued the study due to clinical ly significant hypotension or bradycardia . CONCLUSIONS The comparable efficacy and better tolerability of low-dose mirtazapine versus propranolol , the current first-line treatment for AIA , position mirtazapine as a favorable c and i date for the treatment of acute AIA and may improve current therapeutic practice We aim ed to compare the antidepressant and anxiolytic effects , tolerability and effects on quality of life of mirtazapine and citalopram in a r and omized , double-blind , multicentre , 8-week study . Patients with a Major Depressive Episode ( DSM-IV ) and a baseline score of > or = 22 on the Montgomery-Asberg Depression Rating Scale ( MADRS ) were r and omized to 8 weeks treatment with either mirtazapine  ( n = 137 , 15 - 60 mg/day ) or citalopram ( n = 133 , 20 - 60 mg/day ) . Efficacy was evaluated by the MADRS , Hamilton Anxiety Scale ( HAM-A ) , Clinical Global Impression scales ( CGI ) , the Leeds Sleep Evaluation Question naire ( LSEQ ) and Quality of Life Enjoyment and Satisfaction Question naire ( QLESQ ) . The efficacy analyses were performed on the Intent-To-Treat Group using the Last Observation Carried Forward method . Vital signs and laboratory variables are measured and adverse events recorded at each weekly visit . The magnitude of reduction from baseline in group mean MADRS scores was large in both groups , reaching after 8 weeks of treatment mean scores of 9.1 in the mirtazapine group and 8.9 in the citalopram group . Both treatments also result ed in a substantial improvement in anxiety symptoms , sleep disturbances and quality of life , and high percentage of responders . However , at day 14 , statistically significantly larger magnitudes of change favouring mirtazapine were present in the group mean MADRS , HAM-A and CGI-Severity of illness and Quality of life scores . A difference of 2.3 points on MADRS favouring mirtazapine is considered indicative for a clinical ly relevant superiority between two proven antidepressants . Mirtazapine treatment was also related to faster improvement of sleep , quality of sleep and improved alertness following awakening , as shown by statistically significant differences on the self-rating LSEQ at various time points . There were no differences between two treatment groups on self-rating QLSEQ . Both drugs were well tolerated , with a low number of patients in either group prematurely terminating the study due to adverse events  ( mirtazapine : 3.6 % , citalopram , 3.0 % ) . Sweating and nausea were statistically significantly more frequent in the citalopram group and increased appetite and complaints of weight increase in the mirtazapine group . There were no clinical ly relevant changes in laboratory parameters and vital sign variables with either treatment , except for clinical ly relevant increase in body weight , occurring more frequently in mirtazapine patients . In this study , mirtazapine and citalopram were equally effective in reducing symptoms of depression and anxiety , and well tolerated . However , mirtazapine was significantly more effective than citalopram after 2 weeks of treatment on the MADRS , HAM-A and CGI Severity of illness and Quality of life scales . This finding , consistently present at all major efficacy variables , suggests potentially faster onset of efficacy of mirtazapine over citalopram Patients ( n = 150 ) were r and omized to a 6-week , double-blind study to evaluate the relative efficacy and safety of mirtazapine , amitriptyline , and placebo in the treatment of major depressive disorder symptoms . Average daily modal doses were mirtazapine , 18 mg ; amitriptyline , 111 mg ; and placebo , 4.6 capsules . Mirtazapine- and amitriptyline-treated patients had statistically significantly greater mean Hamilton Rating Scale for Depression ( HAM-D ) score reductions ( weekly visits 1 , 2 , 4 , and endpoint ) compared to placebo . These findings were supported by the Montgomery-Asberg Depression Rating Scale ( MADRS ) ; the Zung Self-rating Depression Scale ( SDS ) ; and the Clinical Global Impressions ( CGI ) scales . Somnolence and weight gain were the only adverse clinical experiences ( ACEs ) reported substantially more often by mirtazapine-treated patients than by those in the placebo group . However , more amitriptyline-treated patients reported decreased visual accommodation , dry mouth , dyspepsia , constipation , tachycardia , hypertension , hypotension , discoordination , dizziness , and tremor than mirtazapine- or placebo-treated patients . Results of this study indicate that mirtazapine is more effective than placebo in the treatment of these patients , and superior to amitriptyline in respect to anticholinergic and cardiovascular effects BACKGROUND Major depressive disorder ( MDD ) is a common and debilitating illness in patients with cancer . However , the optimal treatment of depression in these patients remains uncertain , with limited evidence to support the use of pharmacologic therapy . We conducted a pilot study to evaluate the feasibility of an antidepressant clinical trial in the oncology population and the process of symptom-oriented selection of antidepressants ( citalopram or mirtazapine ) in patients with cancer and MDD . METHODS This was a single center , two-arm , nonr and omized , open-label , nine-week pilot study of mirtazapine or citalopram in cancer patients with MDD . The primary endpoint was the feasibility to recruit and to retain patients . Secondary outcomes included changes in Patient Health Question naire-9 ( PHQ-9 ) ( depression ) , Functional Assessment of Cancer Therapy-General ( FACT-G ) ( quality of life ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) ( fatigue ) , and Pittsburgh Sleep Quality Index ( PSQI ) ( sleep ) . We conducted descriptive statistics and responder analyses . RESULTS Of 21 patients , 18 ( 86 % ) successfully completed the study . An average of 2.8 subjects were enrolled per month . Mean scores on the PHQ-9 improved overall by 6.4 points ( 95 % confidence interval [ CI ] 3.6 - 9.2 ) . Additionally , mean FACT-G , FACIT-Fatigue , and PSQI scores improved in both study arms . CONCLUSION Conducting antidepressant clinical trials is challenging in the oncology population . We approached but did not meet our feasibility goals . Depression and quality of life ( QOL ) scores improved with both mirtazapine and citalopram , but evidence -based pharmacologic treatments for depression in cancer patients are needed Of 580 patients r and omly assigned to short-term , double-blind treatment with either mirtazapine , amitriptyline or placebo , a total of 217 patients clinical ly judged to be responders subsequently continued on the same medication for up to 2 years in the long-term treatment study  ( mirtazapine , n = 74 ; amitriptyline , n = 86 and placebo , n = 57 ) . The efficacy of mirtazapine in relapse prevention was seen in an analysis of the first 20 weeks data . Significantly fewer patients relapsed during treatment with mirtazapine compared with placebo ( p < 0.05 ) , and a significantly longer time to relapse was shown on the survival analysis . There was a significant advantage for amitriptyline compared with placebo in the first 20 weeks , with fewer patients relapsing . There was a significant advantage for mirtazapine compared with amitriptyline at 20 weeks seen on the survival analysis ( p < 0.05 ) . The significant advantage for mirtazapine compared with placebo was also seen in the prophylactic phase of treatment after 20 weeks . At the endpoint there were significantly more patients in the placebo group with a return of symptoms and significantly fewer showing sustained response , Amitriptyline was better than placebo with fewer patients suffering a recurrence of symptoms , but there was no difference from placebo in the proportion of patients with sustained response .  Mirtazapine was well tolerated with a side-effect profile similar to that of placebo . The only adverse event reported significantly more frequently on mirtazapine than on placebo was weight gain . Objective ly measured weight gain was more frequent with amitriptyline ( 22 % of patients ) compared with mirtazapine ( 13 % of patients ) . Amitriptyline was associated with significantly more adverse events than either mirtazapine or placebo , in particular sedative and anticholinergic side effects . The efficacy of mirtazapine in reducing the risk of relapse and the recurrence of depression , which on some measures showed an advantage compared with amitriptyline , coupled with its improved side-effect profile , commends this antidepressant for the long-term treatment of depression BACKGROUND The aim was to compare the efficacy and tolerability of mirtazapine with those of paroxetine . METHOD 275 out patients with a diagnosis of major depressive episode ( DSM-IV ) and a score > or = 18 on the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) were r and omly assigned to 6 weeks of treatment with mirtazapine ( 15 - 45 mg/day ) or paroxetine ( 20 - 40 mg/day ) . Efficacy was assessed by the HAM-D-17 , Hamilton Rating Scale for Anxiety ( HAM-A ) , and Clinical Global Impressions scales ( Severity and Improvement ) , and analyses were performed on the intent-to-treat sample ( 127 mirtazapine-treated patients and 123 paroxetine-treated patients ) . RESULTS Mean daily doses were 32.7 mg of mirtazapine and 22.9 mg of paroxetine . Thirty patients in the mirtazapine group and 33 in the paroxetine group dropped out . Both drugs were equally effective in reducing symptoms of depression . At week 1 , the mean HAM-D-17 total score was significantly lower in mirtazapine- than paroxetine-treated patients ( 16.5 vs. 18.8 , p = .0032 ) . Similarly , significantly more mirtazapine-treated patients were HAM-D-17 responders ( > or = 50 % decrease from baseline ) at weeks 1 ( 23.2 % vs. 8.9 % , p = .002 ) and 4 ( 58.3 % vs. 44.5 % , p = .04 ) . Both treatments were equally effective in reducing anxiety . However , the reduction in mean HAM-A total score was significantly greater with mirtazapine than with paroxetine at week 1 ( -5.1 vs. -3.5 , p = .0435 ) . Tolerability of both treatments was good , with more nausea , vomiting , tremor , and sweating in the paroxetine group and more weight increase and influenza-like symptoms in the mirtazapine group . CONCLUSION Mirtazapine and paroxetine were equally effective after 6 weeks of therapy and were both well tolerated . A potentially faster onset of overall therapeutic efficacy of mirtazapine was suggested by significant differences between treatments after 1 week of therapy that were due to slightly larger improvements of several core symptoms of depression as well as distinct prevention of treatment-emergent worsening of anxiety and physical components of depression
However , mirtazapine showed effectiveness in treating depression , anxiety , sleep disorders , emesis and neuropathic pain .
Across all studies , mirtazapine is safe to use , with drowsiness and dizziness the most common side-effects .
Cancer patients often experience multiple distressing symptoms which are challenging to manage .
It would therefore be helpful to find a treatment that alleviates more than one symptom , to avoid polypharmacy : mirtazapine has been used in several studies for this purpose .
The objective of this study was to assess the effectiveness and safety of mirtazapine in alleviating one or more frequently encountered cancer-related symptoms .