Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms

All patients which agreed to participate and signed the informed consent, were interviewed to be enrolled if they filled the inclusion and exclusion criteria.

The inclusion criteria were: both genders, aged 18 to 60, diagnosis of PTSD DSM-IV criteria by a trained psychiatrist after the application of the SCID-I. Women must be using contraceptive methods during the study. Women had to be using contraceptive methods during the study. The exclusion criteria were to have a diagnostic of the following conditions: schizophrenic disorder, delusional disorder, bipolar disorder, psychotic depression episode and psychoactive substance dependency disorder in the previous 6-month period, instable medical diseases, and pregnancy.

All included patient was submitted at baseline to a socio-demographic inventory and to a psychometric evaluation, the latter were reapplied at weeks 8 and 16. The psychometric evaluation consist of self-report instruments: CAPS to measure PTSD symptoms severity, the Beck Depression Inventory (BDI) [29] and the Beck Anxiety Inventory (BAI) [30] to measure the depressive and the anxiety symptoms severity, the Medical Outcome Scale short form (MOS-SF-36) [31] and the Social adjustment scale (SAS) [32] to evaluate quality of life and social adjustment. A 7.5mg single dose of aripiprazole was prescribed, and the patient was evaluated each two weeks and dose could be increased or decreased depending of their tolerability to side effects. After 16-week the drug was discontinued over a two week period.

Thirty-two outpatients were included after filling the inclusion and exclusion criteria. Twenty-four (75%) were women and 8 (25%) men. Eighteen (56.3%) were married, eight (25%) single, and six (18.7%) were widowed or divorced. Their mean age was 38.41 (+/-10.97) years old, and the mean time since trauma happened was 50.87 (+/-77.21) months. Three (9.4%) patients have been victims of sexual abuse, four (12.5%) kidnapped, four (12.5%) held hostage in prison rebellion, 7 (21.88%) lost a close person to homicide, 8 (18.75%), suffered a homicide attempt.

Nine (28%) patients discontinued the treatment before the second assessment. Six (18.7%) patients discontinued the medication because of adverse events (anxiety, psychomotor agitation, nausea, and insomnia), three (3) patients abandoned the treatment and we lost contact with them. Six (6) patients had at least a second assessment, but did not complete 16-week trial, three due to a complete remission and a resistance to continue on the study and three discontinued due to lack of clinical improvement. The BDI baseline mean score from the dropouters was 28.7 (+/- 12.7) higher compared to the completers 25 (+/- 11.2) showing a statistically significant difference (t=.2167 p<.02) The mean dose was 9.6 (+/-4.3) mg/day, with the dose range of 3.75 to 15 mg day.