Aripiprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00440713

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 III

MedlinePlus related topics: Anxiety Depression Post-Traumatic Stress Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study of Aripriprazole in the Treatment of Post-Traumatic Stress Disorder Symptoms

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

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

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

Keywords provided by Federal University of São Paulo:

Posttraumatic Stress Disorder
Depression
Anxiety
Efficacy

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic

Stress
Aripiprazole
Depressive Disorder
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009