Aripiprazole Augmentation of Antidepressants in PTSD

NCT00489866 | Completed Phase 2 Results

• 1 other identifier: VA IRB#01163
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD

Keywords

PTSD; Antidepressant; Aripiprazole; OEF; OIF

Outcome Measures

Primary Outcomes (3)

• Clinician Administered PTSD Scale (CAPS)

  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.

  Week 2 and Week 6

• Brief Assessment of Cognition in Affective Disorders (BAC-A)

  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).

  Week 2 and Week 6

• Positive and Negative Symptoms Scale (PANSS)

  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)

  Week 2 and Week 6

Secondary Outcomes (2)

• Connor-Davidson Resilience Scale (CD-RISC)

  Week 2 and Week 6

• Beck Depression Inventory, Second Edition (BDI-II)

  Week 2 and Week 6

Study Arms (2)

Aripiprazole

EXPERIMENTAL

Drug: Aripiprazole

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aripiprazole DRUG

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

Aripiprazole

Placebo DRUG

Same as active drug.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VAMC 508 Fulton Street

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

One of the primary limitations of this pilot clinical trial is small sample size. Results of this study will clearly need to be replicated in a larger cohort.

Results Point of Contact

• Title: Christine E. Marx, MD
• Organization: Durham VAMC

marx0001@mc.duke.edu

9192860411

Study Officials

• Christine E Marx, MD, MA

  Durham VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2014
• Last Updated: March 31, 2015
• Results First Posted: March 28, 2012

Record last verified: 2015-03

Locations

US (1)