Fluoxetine in the acute treatment and relapse prevention of combat-related post-traumatic stress disorder: Analysis of the veteran group of a placebo-controlled, randomized clinical trial

The efficacy and safety of fluoxetine (20–80 mg) was compared with placebo in 144 veterans [36.2 years], diagnosed with combat-related post-traumatic stress disorder (PTSD) selected from a 12-week acute and 24-week relapse prevention PTSD trial. In the acute phase, improvements were greater with flu...

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Bibliographic Details
Published inEuropean neuropsychopharmacology Vol. 16; no. 5; pp. 340 - 349
Main Authors Martenyi, Ferenc, Soldatenkova, Victoria
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 01.07.2006
Subjects
Acute treatment
Adult
Aged
Antidepressive Agents, Second-Generation - therapeutic use
Combat-related PTSD
Double-Blind Method
Female
Fluoxetine
Fluoxetine - therapeutic use
Humans
Male
Middle Aged
Placebo
Psychiatric Status Rating Scales
Relapse prevention
Secondary Prevention
Stress Disorders, Post-Traumatic - drug therapy
Stress Disorders, Post-Traumatic - psychology
Survival Analysis
Treatment Outcome
Veterans - psychology
Yugoslavia
Yugoslavia
Acute treatment
Combat-related PTSD
Fluoxetine
Relapse prevention
Placebo
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Summary:The efficacy and safety of fluoxetine (20–80 mg) was compared with placebo in 144 veterans [36.2 years], diagnosed with combat-related post-traumatic stress disorder (PTSD) selected from a 12-week acute and 24-week relapse prevention PTSD trial. In the acute phase, improvements were greater with fluoxetine than placebo in the disease-specific outcome measures: Treatment Outcome PTSD (TOP-8) total scores (SE):− 9.05 (0.90) and − 5.20 (1.23), p = 0.001; Clinician Administered PTSD Scale (CAPS) total scores:−31.12 (2.72) and − 16.07 (4.24), p < 0.001; all CAPS subscores; Davidson Trauma Scale (DTS) total scores; and other general outcome measures. In the maintenance phase, fluoxetine was superior to placebo in sustaining improvement in TOP-8 [− 1.01 (0.91) and 1.56 (0.95)] and CAPS [− 4.93 (3.54) and 5.48 (3.66)]. The risk of relapse in the placebo arm was significantly greater than in the fluoxetine arm (log-rank test χ 2 = 4.090, df = 1, p = 0.048). Fluoxetine was well tolerated at a mean daily dose of 65 mg.
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ISSN:0924-977X
1873-7862
DOI:10.1016/j.euroneuro.2005.10.007