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Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms (AripipPTSD)

This study has been completed.
Information provided by:
Federal University of São Paulo Identifier:
First received: February 22, 2007
Last updated: February 23, 2007
Last verified: February 2007

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

Condition Intervention Phase
Posttraumatic Stress Disorder Drug: Aripiprazole Behavioral: Interpersonal Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • CAPS (Clinician Administered Posttraumatic Scale) score (PTSD symptoms)

Secondary Outcome Measures:
  • Beck Depression Inventory
  • Beck Anxiety Inventory
  • Social Adjustment Scale
  • Global Assessment Functioning
  • MOS SF-36, quality of life
  • Dropout
  • complete the trial

Estimated Enrollment: 40
Study Start Date: January 2004
Estimated Study Completion Date: March 2006
  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of PTSD (after SCID-I application by a trained psychiatrist).
  • Use of an effective contraceptive method when the subject is women with sexual activity and with risk of pregnancy.

Exclusion Criteria:

  • Clinical diagnosis of schizophrenic, delusional, psychotic depression, schizoaffective, bipolar or borderline personality (after SCID-I application by the a trained psychiatrist).
  • Clinical diagnosis of psychoactive substance dependence within 6-months before the study enrollment.
  • To have decompensated medical diagnostics needing urgent treatment
  • being pregnant.
  • using psychoactive drugs.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00440713

Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Marcelo F Mello, M.D. Federal University of São Paulo
  More Information Identifier: NCT00440713     History of Changes
Other Study ID Numbers: 01
Study First Received: February 22, 2007
Last Updated: February 23, 2007

Keywords provided by Federal University of São Paulo:
Posttraumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on July 19, 2017