Table 1.
Controlled clinical trials of psychopharmacologic agents used in the treatment of posttraumatic stress disorder, per medication group, in the order of publication*
| Study, year (ref. No.) | No. of patients | Medication (daily dosage) | Study duration | Main findings |
|---|---|---|---|---|
| TCA | ||||
| Frank et al, 1988 (26) | 62 | imipramine†, phenelzine, placebo | 8 weeks | Both medications, but especially phenelzine, improved IES score |
| Reist et al, 1989 (27) | 18 | dezipramine (100-200 mg), placebo | 4 weeks | No change in PTSD, depression reduced in dezipramine group |
| Davidson et al, 1990 (28) | 46 | amitriptyline (50-300 mg), placebo | 8 weeks | Significant improvement in HAMD score after completed 4 weeks; improvement on other measurement scales after completed 8 weeks of treatment |
| Kosten et al, 1991 (29) | 62 | imipramine (50-300 mg), phenelzine (15-75 mg)placebo | 8 weeks | Both medications superior to placebo |
| Davidson et al, 1993 (30) | 62 | amitriptyline (50-300 mg), placebo | 8 weeks | Reduced anxiety, depression, and IES scores in amitriptyline group |
| MAOI/RIMA | ||||
| Shestatzky et al, 1988 (31) | 13 | phenelzine (45-75 mg), placebo | 5 weeks | No difference |
| Katz et al, 1994-1995 (32) | 45 | brofaromine (50-150 mg), placebo | 14 weeks | Brofaromine significantly reduced PTSD symptoms |
| Baker et al, 1995 (33) | 118 | brofaromine (up to 150 mg), placebo | 12 weeks | No difference in CAPS score; brofaromine improved CGI score |
| SSRI | ||||
| van der Kolk et al, 1994 (34) | 64 | fluoxetine (20-60 mg), placebo | 5 weeks | Fluoxetine effective in PTSD treatment, which may be explained by inclusion of civilian patients |
| Connor et al, 1999 (35) | 53 | fluoxetine (20-60 mg), placebo | 12 weeks | Fluoxetine superior to placebo (civilian PTSD) |
| Hertzberg et al, 2000 (36) | 12 | fluoxetine (10-60 mg), placebo | 12 weeks | No difference in comparison with placebo |
| Brady et al, 2000 (37) | 187 | sertraline (50-200 mg), placebo | 12 weeks | Sertraline superior to placebo |
| Meltzer-Brody et al, 2000 (38) | 53 | Fluoxetine†,placebo | Significant changes in all groups of PTSD symptoms | |
| Martenyi et al, 2007 | 411 | Fluoxetine (20-40 mg), placebo | 12 weeks | No difference on CAPS scale in comparison with placebo |
| Tucker et al, 2001 (39) | 307 | paroxetine (20-50 mg), placebo | 12 weeks | CGI score improvement of 50% in paroxetine group and 43.5% in placebo group |
| Marshall et al, 2001 (40) | 365, 186 | paroxetine (20-40 mg), placebo | 12 weeks | CGI score improved in 63% and 57% of patients receiving paroxetine 20 mg and 40 mg, respectively, and in 37% of patients receiving placebo |
| Davidson et al, 2001 (41) | 100 | sertraline (50-200 mg), placebo | 12 weeks | Sertraline shown to be safe, well-tolerated, and effective treatment for PTSD |
| Stein et al, 2003 (42) | 307 | paroxetine (20-50 mg), placebo | 12 weeks | CGI score improved in 59% of patients receiving paroxetine and 39% of patients receiving placebo |
| Antipsychotic agents | ||||
| Butterfield et al, 2001 (43) | 15 | olanzapine (5-20 mg), placebo | 10 weeks | No difference |
| Hamner et al, 2000 (44) | 40 | risperidone (1-6 mg), placebo | 5 weeks | Significantly reduced PANSS score and symptoms of re-experiencing |
| Stein et al, 2002 (45) | 19 | olanzapine†, placebo | 12 weeks | Despite the small sample, olanzapine and other atypical antipsychotic agents relatively effective in PTSD refractory to SSRI therapy. Especially useful in reducing sleep problems. |
| Bartzokis et al, 2005 (46) | 73 | risperidone + psychotropic medications†, placebo | 4 mo | Added risperidone improved many psychiatric symptoms in patients with chronic war-related PTSD |
| Rothbaum et al, 2008 (47) | 45 (phase 1) 25 (phase 2) | sertraline + risperidone† | 8 weeks (each phase) | sertraline – open study (phase 1) risperidone with sertraline – placebo-controlled (phase 2) |
| Anticonvulsants | ||||
| Hertzberg et al, 1999 (48) | 15 | lamotrigine (25-500 mg), placebo | 12 weeks | Lamotrigine may be effective as a primary psychopharmacologic treatment in war-related and civilian PTSD and as additional therapy to antidepressants in PTSD treatment |
| Other medications | ||||
| Braun et al, 1990 (49) | 16 | alprazolam (2.5-6.0 mg), placebo | 5 weeks | No changes in PTSD clinical picture |
| Kaplan et al, 1996 (50) | 13 | inositol (12 g), placebo | 4 weeks | No effect on PTSD |
*Abbreviations: PTSD – posttraumatic stress syndrome; TCA – tricyclic antidepressants; IES – Impact of Event Scale; HAMD – Hamilton Depression Scale; MAOI – monoamine oxidase inhibitors; RIMA – reversible inhibitor of monoamine oxidase (type A); SSRI – selective serotonin-reuptake inhibitors; CAPS – Clinician-Administered PTSD Scale, CGI – Clinical Global Impressions scale; PANSS – Positive and Negative Syndrome Scale.
†Dosage was not reported in the study.