Aripiprazole Augmentation of Antidepressants in PTSD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00489866
First received: June 20, 2007
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.


Condition Intervention Phase
PTSD
Drug: Aripiprazole
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aripiprazole Augmentation of Antidepressants in PTSD

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]

    Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).

    A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.


  • Brief Assessment of Cognition in Affective Disorders (BAC-A) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
    The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).

  • Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
    The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)


Secondary Outcome Measures:
  • Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
    This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).

  • Beck Depression Inventory, Second Edition (BDI-II) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
    The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).


Enrollment: 14
Study Start Date: March 2007
Estimated Study Completion Date: August 2014
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole Drug: Aripiprazole
Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
Placebo Comparator: Placebo Drug: Placebo
Same as active drug.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Outpatient veterans with posttraumatic stress disorder (PTSD)
  • Receiving treatment with an antidepressant at a stable dose for 4 weeks
  • Male or female
  • Ages 18-65 years old
  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: NCT00489866

Locations
United States, North Carolina
Durham VAMC 508 Fulton Street
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
  More Information

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00489866     History of Changes
Other Study ID Numbers: VA IRB#01163
Study First Received: June 20, 2007
Results First Received: September 16, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Durham VA Medical Center:
PTSD
Antidepressant
Aripiprazole
OEF
OIF

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

ClinicalTrials.gov processed this record on August 20, 2014