A double-blind randomized study comparing imipramine with fluvoxamine in depressed inpatients.
OBJECTIVE
To compare the efficacy of imipramine and fluvoxamine in inpatients from two centers suffering from a depressive disorder according to DSM IV criteria.


METHODS
The study included 141 patients with a depressive disorder according to DSM IV criteria. After a drug-free and placebo run-in period of 1 week, patients were randomized to imipramine or fluvoxamine; doses of both drugs were adjusted to a predefined target blood level. Efficacy was evaluated 4 weeks after attaining predefined adequate plasma level.


RESULTS
The mean age of the study group (47 males, 94 females) was 51.8 (range 19-65) years. Of these 141 patients, 56 had episode duration longer than 1 year, 48 had mood congruent psychotic features, and 138 patients received medication. Seven patients did not complete the medication trial. The total number of patients using concurrent medication was 12/138 (8.6%). On the primary outcome criteria patients on imipramine improved significantly better on the change of illness severity score of the CGI (chi2 exact trend test=4.089, df=1, P=-0.048). There was no significant difference in 50% or more reduction on the HRSD, the other primary outcome criterion. On the secondary outcome criteria the mean reduction of the HRSD scores was significantly larger in the imipramine group than in the fluvoxamine group (mean difference=3.1, standard error (SE)=1.4, t=2.15, df=136, P=0.033). There was no significant difference in the number of patients with an HRSD < or =7 at the final evaluation.


CONCLUSIONS
In depressed inpatients imipramine is more efficacious than fluvoxamine. Both drugs were well tolerated by all patients.
van den Broek
Walter W
WW
Department of Psychiatry, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, The Netherlands. w.w.vandenbroek@erasmusmc.nl
Birkenhäger
Tom K
TK
Mulder
Paul G H
PG
Bruijn
Jan A
JA
Moleman
Peter
P
D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D007099:Imipramine / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D007297:Inpatients; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010352:Patient Dropouts; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D000929:Antidepressive Agents, Tricyclic; D016666:Fluvoxamine; D007099:Imipramine