Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      32 outpatients with a Posttraumatic Stress Disorder were included in a randomized comparative
      single-blind study to study the efficacy of aripiprazole to treat post-traumatic stress
      symptoms.

      The hypothesis is that aripiprazole has an efficacy to reduce PTSD symptoms
    

Detailed description: 
      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.

      An intention-to-treat analysis using the Last Observation Carried Forward (LOCF) including
      the baseline outcome data found a CAPS mean score at baseline of 82.7 (+/- 23.1) and 51.4
      (+/-31.4) on endpoint, over 38% reduction from the baseline. Comparing the data using the t
      test the difference between before and after the treatment was statistically significant
      (t=.000002, p<.001 - Table and Graph 1).

      When using a concept of 30% decrease at CAPS mean score from baseline as a response to
      treatment, 17 (53.1%) patients have a response, and when using a more restrictive concept of
      50% decrease at CAPS mean score 13 (40.6%) patients responded to the treatment.

      The mean BAI score at baseline was 31.7 (+/- 13.4) and at the end-point were 25.4 (+/-18.2)
      (t=.01, p<.05) The SAS mean index score at baseline was 2.4 (+/-.45) and on the endpoint 2.27
      (+/- .57) (t=.033, p<.05). The SF-36 mean score at baseline was 76.6 (+/-14.11) and at
      baseline 94.01 (+/- 25.06) (t=.0006, p<.05). On all measures, excepted on BDI, the
      differences between baseline and endpoint means were statistically significant. On the BDI
      with a mean score at baseline of 26.06 (+/- 11.6) and at the end-point of 21.35 (+/-12.6),
      the difference wasn't statistically significant (t=.58, p<.05).
    

Intervention name(s): Aripiprazole; Interpersonal Therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Depression; Anxiety; Efficacy