A Naturalistic Long-Term Comparison Study of Selective Serotonin Reuptake Inhibitors in the Treatment of Panic Disorder A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder. A fixed-dose clinical trial of fluoxetine in outpatients with major depression. Fluoxetine versus trimipramine in the treatment of depression in geriatric patients. A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients. A multicentre open trial of fluoxetine in depressed out-patients in Belgium. A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. A comparative trial of fluoxetine versus trazodone in outpatients with major depression. Fluoxetine treatment of patients with major depressive disorder who failed initial treatment with sertraline. Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors. Double-blind controlled study on the clinical efficacy and safety of fluoxetine vs clomipramine in the treatment of major depressive disorders. Compliance with antidepressant medication in the treatment of major depressive disorder in primary care: a randomized comparison of fluoxetine and a tricyclic antidepressant. Gender differences in the efficacy of fluoxetine and maprotiline in depressed patients: a double-blind trial of antidepressants with serotonergic or norepinephrinergic reuptake inhibition profile Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. Is Baseline Agitation a Relative Contraindication for a Selective Serotonin Reuptake Inhibitor: A Comparative Trial of Fluoxetine Versus Imipramine Comparison of equivalence between the St. John's wort extract LoHyp-57 and fluoxetine. A comparative trial of fluoxetine and amitriptyline in patients with major depressive disorder.
Objectives : Selective serotonin reuptake inhibitors ( SSRIs ) are currently considered as the first drug of choice in the treatment of panic disorder ( PD ) . The aim of this long-term , naturalistic comparison study was to compare 4 SSRIs with respect to tolerability and treatment outcome of PD . Outcome measures included relapse rates and adverse effects . Methods : Two hundred patients with PD were enrolled in our study . All subjects met DSM-IV criteria for PD or PD with agoraphobia ( PDA ) . All patients were assigned to receive SSRI monotherapy for 12 months with either citalopram ( n = 50 ) , fluoxetine ( n = 50 ) , fluvoxamine ( n = 50 ) , or paroxetine ( n = 50 ) in a r and omized , nonblinded fashion . Both the treating psychiatrist and the patients were not blind to the assigned treatment , but the clinician raters were blind to the study medication . The study design allowed for assignment of a particular SSRI as indicated according to the clinical judgment of the study psychiatrists . The Panic Self- Question naire , which is a self-report scale , was administered at baseline and then once per month during the duration of the 12-month study . The visual analog scale and the Clinical Global Impression Scale were administered at baseline and then once per month during the period of the study . Reports of sexual dysfunction were assessed using a nonstructured clinical interview at monthly visits . The body weight of study subjects was measured at baseline , and then at the 12th month visit end point . Results : Of 200 patients who entered the study , 127 patients ( 63.5 % ) completed the full 12-month protocol . Retention rates were highest for paroxetine ( 76 % [ 38/50 ] ) , intermediate for citalopram ( 68 % [ 34/50 ] ) and fluvoxamine ( 60 % [ 30/50 ] ) , and lowest for fluoxetine ( 50 % [ 25/50 ] ) . Patients who completed the 12-month protocol responded favorably to the study treatment . The paroxetine and the citalopram groups had significantly lower rates of panic symptoms as measured at visits on weeks 4 and 8 . At visits on months 3 , 6 , 9 , and 12 , however , there were no statistically significant differences between the 4 groups in relapse rates ( defined as the occurrence of 1 or more panic attacks during the previous week of treatment ) ( F1,127 = 0.17 ; P = 0.13 [ not statistically significant ] ) . At the 12th month end point , patients in all 4 treatment groups had a statistically significant increase in body weight . Body weight among the study population increased by 6.1 + 4.9 kg from a mean weight of 72.4 + 7.3 kg at the onset of treatment . Reports of sexual adverse effects at the 12th month visit were similar in the citalopram , fluoxetine , and paroxetine groups , but the fluvoxamine patient group reported fewer sexual adverse effects at the 12th month visit . Conclusions : Most of our PD patients responded well to 12-month treatment with either citalopram , fluoxetine , fluvoxamine , or paroxetine , and the overall response rate was equal after the first 4 weeks of treatment . Although patients treated with paroxetine had the lowest dropout rates during the initiation phase , they had the highest rate of adverse effects as measured at the 12th month visit . Conversely , patients in the fluvoxamine group had the highest dropout rate ( which was primarily caused by adverse effects in the initiation phase of treatment . ) ; however , patients who were able to tolerate fluvoxamine throughout the full course of the study were observed to have lower rates of sexual dysfunction and weight gain compared with patients treated with the other agents . Overall , when measured at the 12th month visit , monotherapy with paroxetine and citalopram was associated with a higher rate of sexual adverse effects than was treatment with fluoxetine or fluvoxamine . In addition , monotherapy with paroxetine , citalopram , and fluoxetine seemed to cause more weight gain than did treatment with fluvoxamine BACKGROUND Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors . In a 12-week r and omized , multicenter , double-blind trial , the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in patients with moderate to severe depression . METHODS A total of 203 patients were r and omized to fixed doses ( 20 mg/day ) of paroxetine or fluoxetine for the first six weeks of therapy . From week 7 - 12 , dosing could be adjusted biweekly , as required ( paroxetine 20 - 50 mg/day , and fluoxetine 20 - 80 mg/day ) . The mean prescribed doses were paroxetine 25.5 mg/day ( range 20.0 - 40.2 mg/day ) , and fluoxetine 27.5 mg/day ( range 20.0 - 59.5 mg/day ) . Emergence of motor nervousness or restlessness was assessed using the ESRS scale for akathisia . RESULTS Both active treatments demonstrated comparable antidepressant efficacy ( HAM-D , CGI ) . Anxiolytic activity of the two drugs ( COVI , STAI , HAM-D ) was also comparable . However , paroxetine was found to be superior to fluoxetine on two subscore measures at week 1 of therapy ( HAM-D Agitation item , p < 0.05 ; Psychic Anxiety item , p < 0.05 ) , with no differences detected after week 2 . The overall incidence of adverse effects was comparable in the two treatment groups . Constipation , dyspepsia , tremor , sweating and abnormal ejaculation were more common in paroxetine-treated subjects , whereas nausea and nervousness were more frequent in fluoxetine-treated patients . Weight loss was more common in the fluoxetine versus paroxetine group ( 11.88 % versus 2.94 % , respectively ) . ESRS scores for akathisia were low throughout the study and showed little change . LIMITATIONS Differences observed between the two drugs in antianxiety effects were limited to two measures of anxiety among several others . DISCUSSION The data indicate that paroxetine and fluoxetine have comparable antidepressant and anxiolytic efficacy .  Paroxetine appears to produce an earlier improvement in agitation and psychic anxiety symptoms compared with fluoxetine Fixed daily doses of 20 mg , 40 mg , or 60 mg of fluoxetine , a highly specific serotonin reuptake inhibitor , were given to 84 depressed out patients in a double-blind , placebo-controlled , r and omized 6-week trial . The 20-mg dose produced improvement of depression in the moderate-severe depression group as expressed in significant reductions of scores on the Hamilton Rating Scale for Depression ( p greater than or equal to .007 ) and the Patient Global Impressions scale ( p greater than or equal to .011 ) , and the 20-mg dose caused fewer side effects than did the higher doses . A mildly depressed group of patients showed no improvement at any dose level of fluoxetine INTRODUCTION Fluoxetine , a selective serotonin reuptake inhibitor ( SSRI ) , and trimipramine , a tricyclic antidepressant ( TCA ) , were compared in terms of efficacy and tolerability in a six-week , parallel group , double-blind pilot study in 41 geriatric patients with major depression ( 61 - 85 years old ) . METHOD The Hamilton Rating Scale for Depression ( HAMD-17 ) , the Montgomery-Asberg Rating Scale ( MADRS ) , the Adjective Mood Scale ( Bf-S ) , the Clinical Global Impression ( CGI ) , and the Patients Global Impression ( PGI ) were used to measure changes in depressive symptoms . RESULTS Improvement with treatment was found on all scales . Efficacy and tolerability were similar in both groups . No statistically significant differences were found . CONCLUSION These findings suggest that fluoxetine and trimipramine are comparable in terms of efficacy and tolerability in the treatment of major depression in geriatric patients BACKGROUND There has been a paucity of well- design ed studies comparing selective serotonin reuptake inhibitor ( SSRI ) medications in the treatment of depression in the elderly . This multicenter study was design ed to examine the efficacy and safety of sertraline and fluoxetine in depressed elderly out patients . A secondary objective was to examine the effects of SSRI treatment on quality of life and cognitive function . METHOD Two hundred thirty-six out patients 60 years of age and older who met DSM-III-R criteria for major depressive disorder received 1 week of single-blind placebo before being r and omly assigned to 12 weeks of double-blind , parallel-group treatment with flexible daily doses of either sertraline ( range , 50 - 100 mg ) or fluoxetine ( range , 20 - 40 mg ) . Primary efficacy measures consisted of the 24-item Hamilton Rating Scale for Depression and Clinical Global Impressions scale ratings . Secondary outcome assessment s included clinician- and patient-rated measures of depression symptoms and factors , cognitive functioning , and quality of life , as well as plasma drug concentrations , which were correlated with clinical response . RESULTS Both drugs produced a similarly positive response on the primary efficacy measures , with 12-week responder rates of 73 % for sertraline and 71 % for fluoxetine . Sertraline-treated patients showed statistically greater cognitive improvement on several measures . Both drugs were safe and well tolerated . CONCLUSION Data indicate that both drugs are effective antidepressants for the treatment of depressed elderly out patients . Differences in cognitive performance effects deserve further investigation Fluoxetine hydrochloride ( ProzacR , Lilly ) , a new antidepressant that specifically inhibits serotonin reuptake was evaluated in an open comparative trial performed in 8 Belgian centres over a period of 9 months . Seventy-six out patients were enrolled of which 66 were evaluable . Thirty-six patients received an 8 week fluoxetine treatment and 31 patients received tricyclic antidepressants ( TCA ) . Patients from both treatment groups were evaluated for safety and the fluoxetine treated group of patients was assessed for efficacy . On the Hamilton Depression Scale , the mean score dropped from 26.4 to 7.0 after 8 weeks ( p less than 0.0001 ) . The Clinical and Patient 's Global Impression scores showed a similar evolution . Patients treated with fluoxetine tended to report fewer side-effects than the TCA treated group . Therefore fluoxetine can be regarded as an efficient antidepressant which is at least as well tolerated as TCAs BACKGROUND Sertraline and fluoxetine have pharmacokinetic and pharmacologic differences , which may be of clinical relevance . METHOD A r and omized , double-blind , parallel-group study of 6 weeks ' duration comparing the efficacy and safety of sertraline ( 50 - 100 mg/day ) with those of fluoxetine ( 20 - 40 mg/day ) was conducted in 286 psychiatric out patients with DSM-III-R major depression or bipolar disorder ( depressed ) . Primary efficacy measurements consisted of the 17-item Hamilton Rating Scale for Depression ( HAM-D ) and the Clinical Global Impressions ( CGI ) scale . Secondary measurements included the Hamilton Rating Scale for Anxiety ( HAM-A ) , the Raskin Depression Scale , the Covi Anxiety Scale , and the Leeds Sleep Question naire . Additionally , scores for two items and five factors from the HAM-D were analyzed . RESULTS Efficacy was based on 124 evaluable patients in each treatment group . As measured by HAM-D and CGI-Severity scores , there was a significant ( p < .001 ) improvement from baseline to each follow-up visit in both treatment groups with no statistically significant difference between groups . There was also no significant difference in the proportion of responders in each group . CGI-Improvement responder rates were 69 % for sertraline and 67 % for fluoxetine . Results of secondary efficacy measurements followed the same trend , although from the second week of treatment there was a numerical advantage ( not statistically significant ) for sertraline over fluoxetine in improving anxiety symptoms as measured by the total HAM-A score . Headache and nausea were the most frequently reported events for both drugs . The incidence of early patient withdrawals due to treatment-emergent adverse events was 14 % for sertraline and 13 % for fluoxetine . The starting dosage ( sertraline 50 mg/day , fluoxetine 20 mg/day ) was the final dosage in 76 % of patients in both treatment groups . CONCLUSION Sertraline and fluoxetine were equally effective and well tolerated in patients with major depression and associated anxiety The effectiveness of fluoxetine as an antidepressant was contrasted with trazodone in a 6-week double-blind trial in 40 patients . The total score on the Hamilton Rating Scale for Depression and the global improvement score on the Clinical Global Impressions scale favored trazodone at the end of 3 weeks of treatment . However , that difference was no longer apparent during the remainder of the study . The authors hypothesize that fluoxetine 20 mg/day may be an ineffective dosage of the drug or that fluoxetine has a slower onset of antidepressant action than does trazodone BACKGROUND This study was conducted to determine if patients with major depressive disorder who had previously failed treatment with one serotonin selective reuptake inhibitor ( SSRI ) would respond to a different SSRI . METHOD Adult out patients ( N = 106 ) with DSM-III-R major depressive disorder and a history of either intolerance ( N = 34 ) or nonresponse ( N = 72 ) to treatment with sertraline  were treated with fluoxetine ( mean dose = 37.2 mg/day ) in a st and ardized , open-label , 6-week clinical trial . Outcome was assessed at each visit using the Hamilton Rating Scale for Depression ( HAM-D ) , the Clinical Global Impressions ( CGI-Improvement and CGI-Severity ) scales , and the Patient 's Global Improvement ( PGI ) scale . RESULTS Ninety-one patients ( 86 % ) completed the study . Sixty-seven patients ( 63 % ) responded to fluoxetine ( i.e. , experienced > or = 50 % reduction in HAM-D28 total score at endpoint versus baseline ) . In addition , clinical ly and statistically significant improvements were noted on all measures of depressive symptoms and global functioning . There was a nonsignificant trend for patients with a history of less vigorous sertraline trials to respond more favorably to fluoxetine . Fluoxetine therapy was generally well tolerated , and there were only slight differences in adverse events reported by patients who had been intolerant to sertraline versus those who were nonresponders . CONCLUSION These findings indicate that fluoxetine and sertraline , two widely used SSRIs , are not interchangeable . Patients who either have had trouble tolerating or have not responded to sertraline may do well on fluoxetine treatment BACKGROUND The effect of extended anti-depressant treatment on weight has been poorly investigated . Also unknown is whether different compounds have differential effects . The aim of the present study was to assess changes in weight in obsessive-compulsive disorder ( OCD ) patients treated for 2.5 years with  clomipramine or selective serotonin reuptake inhibitors . METHOD 138 DSM-IV OCD patients who responded to 6-month acute treatment at the Mood and Anxiety Disorders Unit , Department of Neuroscience , University of Turin , Italy , were followed-up for 2 years while receiving open-label clomipramine , citalopram , fluoxetine , fluvoxamine , paroxetine , or sertraline .  Patients were consecutively recruited and followed from May 1998 to March 2003 . The mean percentage change in weight was compared for each group , as was the proportion of patients who had a > or = 7 % weight increase from baseline . RESULTS At the end of the 2.5-year study period , patients had gained a mean of 2.5 % of their body weight with respect to baseline ( 1.58 kg ) ; 14.5 % of the total sample experienced a significant ( > or = 7 % ) weight increase . Within each but the fluoxetine treatment group , paired t tests showed a significant increase in weight from baseline to final visit . Analysis of variance showed a significant difference between treatment groups ( p = .009 ) , with clomipramine being associated with the highest weight increase and fluoxetine and sertraline with the lowest . A higher proportion of clomipramine-treated patients ( 34.8 % ) gained > or = 7 % in weight as compared with sertraline and fluoxetine , which accounted for the lowest percentage of patients with a significant weight gain ( 4.5 % and 8.7 % , respectively ) , although this difference was not statistically significant . CONCLUSION Risk of weight gain during extended serotonin reuptake inhibitor treatment for OCD differs depending on which compound is used . The differences among antiobsessive drugs may affect compliance with medication and health risks In the present double-blind controlled study the efficacy and safety of fluoxetine 20 mg/day versus clomipramine 75 mg/day was evaluated during 5 weeks of treatment in 30 hospitalized patients . The sample was selected according to DSM III criteria for major depressive disorders with a score of at least 18 on the first 17 items of the Hamilton Rating Scale for Depression ( HRSD ) . Therapeutic efficacy was evaluated weekly by using HRSD , Zung Self Rating Scale for Depression , Montgomery-Asberg Scale for Depression , Clinical Global Impression for severity and improvement of depressive symptoms . Safety was monitored weekly by recording body weight , blood pressure , pulse rate , temperature , physical conditions , laboratory tests , adverse experiences and concomitant medication . The results confirm the effectiveness and good tolerability of fluoxetine in the treatment of depressive disorders OBJECTIVE Many cl aims have been made for superior compliance with selective serotonin reuptake inhibitors ( SSRIs ) compared with tricyclic antidepressants , but to date meta-analyses have not confirmed reduced dropouts in r and omized controlled trials . The authors used a r and omized study design to evaluate differential compliance with antidepressant medications in a primary care setting . METHOD A total of 152 patients treated in 10 primary care practice s in the United Kingdom were included in a r and omized , open-label , parallel-group study of fluoxetine and dothiepin at therapeutic doses for 12 weeks . Compliance was assessed by using pill count , patient question naires , and the Medication Event Monitoring System . RESULTS The level of compliance with fluoxetine was numerically higher than the level of compliance with dothiepin on all three primary outcome measures , although the differences were not significant . In a secondary analysis using data from the Medication Event Monitoring System , both a survival analysis for length of time without a gap in medicine taking and a derived compliance index showed a significant advantage to fluoxetine . Patients in the fluoxetine group reported superior response on the health transition scale of the 36-item Short-Form Health Survey Question naire and numerically greater improvement on the Hamilton Depression Rating Scale . In both treatment arms patients with a superior compliance index were more likely to have improved in Hamilton depression scale scores by the last study visit . CONCLUSIONS This study supports recent meta-analyses of SSRIs versus tricyclic antidepressants in finding no significant differences in crude indices of compliance between fluoxetine and dothiepin , despite marked differences in side effect profile and dose regimen . However , both a survival analysis and a new measure that takes account of prolonged periods of noncompliance distinguished between the treatments and was associated with improvement in both groups BACKGROUND Depression has emerged as a contrastive area of gender differences in psychiatry , as epidemiological data has consistently shown depression is twice as common in women as men . The pharmacodynamic effect of antidepressants may also show gender differences , as suggested by reports of better response of young women to non-tricyclic antidepressants . METHODS The antidepressive effect of an SSRI ( fluoxetine ) and a tetracyclic antidepressant with selective norepinephrine reuptake inhibitory effect ( maprotiline ) was compared in a 6-week , double-blind trial of 105 depressed patients . RESULTS No significant difference was observed in the change of HAMD17 total score from baseline to week 6 between fluoxetine- and maprotiline-treated patients . A significant difference was observed in females ( fluoxetine , -17.8 ; maprotiline , -13.9 ; P=0.017 ) between treatment groups , but not in males . Amongst females , the difference was significant in women aged < 44 years  ( fluoxetine , -18.4 ; maprotiline , -12.9 ; P=0.023 ) but not > or = 44 years . CONCLUSIONS Females in their reproductive period are more responsive to SSRI ( fluoxetine ) than norepinephrinergic tetracyclic antidepressant ( maprotiline ) treatment . Normal cyclical ovulation , and estrogen release may have a clinical ly relevant pharmacodynamic interaction with serotonergic antidepressants CONTEXT Selective serotonin reuptake inhibitors ( SSRIs ) are the most commonly prescribed class of antidepressant , yet it is not known whether one SSRI is more effective than another . OBJECTIVE To compare the effectiveness of 3 SSRIs ( paroxetine , fluoxetine , and sertraline ) in depressed primary care patients . DESIGN Open-label , r and omized , intention-to-treat trial , with patient enrollment occurring in April-November 1999 . SETTING Thirty-seven clinics in 2 US primary care research networks . PATIENTS A total of 573 depressed adult patients for whom their primary care physician thought that antidepressant therapy was warranted and who completed a baseline interview . INTERVENTIONS Patients were r and omly assigned to receive paroxetine ( n = 189 ) , fluoxetine ( n = 193 ) , or sertraline ( n = 191 ) for 9 months . Primary care physicians were allowed to switch patients to a different SSRI or non-SSRI antidepressant if they did not adequately respond to or tolerate the initial SSRI . MAIN OUTCOME MEASURES The primary outcome measure was change in the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) Mental Component Summary score ( range , 0 - 100 ) , compared across treatment groups at 1 , 3 , 6 , and 9 months . Secondary outcomes included other depression and psychological measures , multiple measures of social and work functioning , and other domains of health-related quality of life , such as physical functioning , concentration and memory , vitality , bodily pain , sleep , and sexual functioning . RESULTS Follow-up interviews were successfully completed in 94 % of patients at 1 month , 87 % at 3 months , 84 % at 6 months , and 79 % at 9 months . Responses to the 3 SSRIs were comparable on all measures and at all time points . The mean change in the SF-36 Mental Component Summary score at 9 months was + 15.8 in the paroxetine group , + 15.1 in the fluoxetine group , and + 17.4 in the sertraline group . The drugs were also associated with similar incidences of adverse effects and discontinuation rates . CONCLUSIONS The SSRI antidepressants paroxetine , fluoxetine , and sertraline were similar in effectiveness for depressive symptoms as well as multiple domains of health-related quality of life over the entire 9 months of this trial A common presentation for major depression includes psychomotor agitation . However , this subtype has been the infrequent subject of controlled investigation during depression trials . Yet , the subcategorization of agitated depression has historically been associated with the belief that older , sedating compounds have a superior risk : benefit profile . In the 8-week , double-blind , r and omized , parallel trial , 124 subjects with Research Diagnostic Criteria -compatible agitated depression were r and omized to either imipramine ( IMI ) or fluoxetine ( FLU ) . Both compounds proved to be similarly effective as measured by change in HAM-D17 , HAM-D17 response , and HAM-D17 remission rates . Similar comparability was seen in secondary measures of agitation , anxiety , suicidality , and global impressions . However , of note , a statistically significant difference in early discontinuations because of intolerable adverse events emerged . Whereas 43.5 % of IMI subjects discontinued early , only 9.7 % of FLU subjects ( p < 0.001 ) did . Significantly more central nervous system events characterized the IMI than the FLU subgroup ( IMI , 24.2 % , vs. FLU , 6.5 % ; p = 0.006 ) . In conclusion , among subjects with major depression , subtype agitated , the risk : benefit profile favored FLU over IMI . This was driven by the superior tolerance of FLU . No evidence emerged in support of the clinical hypothesis that a “ sedating ” agent is the treatment of choice for this group . The results are important when striving to maximize compliance with pharmacotherapy in order to minimize recidivism and associated psychological and economic morbidity . ( J Clin Psychopharmacol 1994;14:385–391 In a r and omised double-blind comparative trial , the antidepressant efficacy of a daily dose of 800 mg of the St. John 's wort extract LoHyp-57 ( dry extract of St. John 's wort , drug extrakt ratio 5 - 7:1 , solvent , ethanol 60 % [ w/w ] ) was shown to be equivalent to that of 20 mg fluoxetine ( CAS 54910 - 89 - 3 ) in elderly patients with mild or moderate depressive episodes according to ICD 10 ( International Statistical Classification of Diseases and Related Health Problems ) . Treatment was given for six weeks . 149 out- patients ( 129 females and 20 males ) were included in the intention-to-treat analysis . 72 of these patients were assigned to the ICD 10 diagnostic criterion F32.0 ( mild depressive episode ) , while 77 patients were suffering from moderate depressive episodes , corresponding to F32.1 . The principal target criterion was the patient 's global score on the HAMILTON Depression Scale ( items 1 - 17 ) . During the six-week course of treatment with LoHyp-57 , the HAMILTON global score fell from 16.60 points at entry to 7.91 points , and in the fluoxetine sample it fell from 17.18 to 8.11 points . In the group of patients with mild depressive episodes , the score showed a mean fall from 14.21 to 6.21 points on LoHyp-57 , and from 15.21 to 7.46 points on fluoxetine . In patients with moderate depressive episodes , the score showed a mean fall from 18.73 to 9.43 points on LoHyp-57 and from 19.10 to 8.75 points on fluoxetine . The efficacy of both medications was found to be equivalent both in mild and moderate depressive episodes . Both treatment groups showed adverse drug reactions ( ADRs ) . Twelve ADRs with a possible relationship to the study medication were reported during treatment with LoHyp-57 . Six patients were prematurely withdrawn from treatment with the study medication for this reason . On fluoxetine 17 ADRs occurred with a possible relationship to the study medication . These led to ab and onment of treatment and therefore premature withdrawal from the study in 8 cases The efficacy and safety of fluoxetine , a new antidepressant agent , were assessed in a double-blind , parallel , r and omized study of 44 out patients with major depressive disorder . Following a 1-week placebo period , patients were r and omly assigned to either fluoxetine or amitriptyline for a period of 5 weeks . The mean maintenance dosages were 55 mg/day for fluoxetine and 159 mg/day for amitriptyline . Both drugs were effective in relieving the symptoms of depression . The most frequently reported side effects were nausea and nervousness for fluoxetine , and dry mouth , dizziness , and drowsiness for amitriptyline
Conclusions : International differences in prescriber behaviour may influence , and in turn be influenced by , the conduct of clinical trials .
Objective : International differences are thought to exist in dosages used by clinicians treating mood disorders .
This study examined international dosage differences in antidepressant clinical trials , using a data base formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine .