Aripiprazole Augmentation of Antidepressants in PTSD

• ClinicalTrials.gov Identifier: NCT00489866
• Recruitment Status: Completed
• First Posted: June 21, 2007
• Results First Posted: March 28, 2012
• Last Update Posted: March 31, 2015
• Sponsor: Durham VA Medical Center
• Information provided by (Responsible Party): Durham VA Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PTSD	Drug: Aripiprazole; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Aripiprazole Augmentation of Antidepressants in PTSD
• Study Start Date: March 2007
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 2 and Week 6 ]

   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.

2. Brief Assessment of Cognition in Affective Disorders (BAC-A) [ Time Frame: Week 2 and Week 6 ]
   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).
3. Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Week 2 and Week 6 ]
   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 :

1. Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Week 2 and Week 6 ]
   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).
2. Beck Depression Inventory, Second Edition (BDI-II) [ Time Frame: Week 2 and Week 6 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Durham VA Medical Center
• ClinicalTrials.gov Identifier: NCT00489866
• Other Study ID Numbers: VA IRB#01163
• First Posted: June 21, 2007
• Results First Posted: March 28, 2012
• Last Update Posted: March 31, 2015
• Last Verified: March 2015

Keywords provided by Durham VA Medical Center:

PTSD; Antidepressant; Aripiprazole; OEF; OIF

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Aripiprazole; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists