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Completed

NCT Number: NCT00489866

Aripiprazole Augmentation of Antidepressants in PTSD

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Durham VAMC 508 Fulton Street

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Same as active drug.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2014
First posted
Jun 21, 2007
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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