Long-term treatment of depression with nefazodone.
The utility of double-blind continuation data in assessing long-term efficacy was evaluated in an analysis of data from the development program of a new antidepressant, nefazodone. The benefit of nefazodone therapy was examined during continuation treatment of patients who improved during the 6-8 week acute phase of efficacy studies. Discontinuation for lack of efficacy was used as an indicator of relapse. Pooled long-term data from the extension phases of placebo-controlled, acute efficacy trials were analyzed by the Kaplan-Meier method to estimate survival curves for time to discontinuation. Both nefazodone (p < .01) and imipramine (p < .05) were more effective than placebo during long-term continuation therapy. The findings demonstrate the value of double-blind continuation data in the evaluation of long-term drug benefit and provide an early assessment of nefazodone's effectiveness in continuation treatment of major depression.
Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT 06492-7660.
S F
SF
Anton
D S
DS
Robinson
D L
DL
Roberts
T T
TT
Kensler
P A
PA
English
D G
DG
Archibald
D000928:Antidepressive Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D006801:Humans; D007099:Imipramine / Q000627:therapeutic use; D010879:Piperazines; D014230:Triazoles / Q000627:therapeutic use*
D000928:Antidepressive Agents; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone; D007099:Imipramine