NCT00440713

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 22, 2007

Last Update Submit

February 23, 2007

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress DisorderDepressionAnxietyEfficacy

Outcome Measures

Primary Outcomes (1)

  • CAPS (Clinician Administered Posttraumatic Scale) score (PTSD symptoms)

Secondary Outcomes (7)

  • Beck Depression Inventory

  • Beck Anxiety Inventory

  • Social Adjustment Scale

  • Global Assessment Functioning

  • MOS SF-36, quality of life

  • +2 more secondary outcomes

Interventions

AripiprazoleDRUG
Interpersonal TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marcelo F Mello, M.D.

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 27, 2007

Study Start

January 1, 2004

Study Completion

March 1, 2006

Last Updated

February 27, 2007

Record last verified: 2007-02