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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| Published in | European neuropsychopharmacology Vol. 16; no. 5; pp. 340 - 349 |
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| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.07.2006
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| Abstract | 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. |
|---|---|
| AbstractList | 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 chi 2 = 4.090, df = 1, p = 0.048). Fluoxetine was well tolerated at a mean daily dose of 65 mg. 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. 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 chi 2 = 4.090, df = 1, p = 0.048). Fluoxetine was well tolerated at a mean daily dose of 65 mg. |
| Author | Soldatenkova, Victoria Martenyi, Ferenc |
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| Keywords | Acute treatment Combat-related PTSD Fluoxetine Relapse prevention Placebo |
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| SubjectTerms | 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 |
| Title | 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 |
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