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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00440713
First received: February 22, 2007
Last updated: February 23, 2007
Last verified: February 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440713

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Marcelo F Mello, M.D. Federal University of São Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00440713     History of Changes
Other Study ID Numbers: 01
Study First Received: February 22, 2007
Last Updated: February 23, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014