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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00440713
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : February 27, 2007
Sponsor:
Information provided by:
Federal University of São Paulo

Brief 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


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Aripiprazole Behavioral: Interpersonal Therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms
Study Start Date : January 2004
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Beck Depression Inventory
  2. Beck Anxiety Inventory
  3. Social Adjustment Scale
  4. Global Assessment Functioning
  5. MOS SF-36, quality of life
  6. Dropout
  7. complete the trial


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440713


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

ClinicalTrials.gov Identifier: NCT00440713     History of Changes
Other Study ID Numbers: 01
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs