PTSDPhase 2NCT00489866

Aripiprazole Augmentation of Antidepressants in PTSD

A Phase 2 study testing Aripiprazole in people with PTSD, run by Durham VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: PTSD
What is being tested?: Aripiprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VAMC 508 Fulton Street
Durham, North Carolina, 27705

Other trials in United States

About this study

Conditions: PTSD
Being tested: Aripiprazole, Placebo
Keywords: PTSD, Antidepressant, Aripiprazole, OEF, OIF
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AripiprazoleDrug
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
PlaceboDrug
Same as active drug.

Study groups in NCT00489866
Study group	Role	What they receive
Aripiprazole	Experimental	Not described Receives: Drug: Aripiprazole
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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)
Measured: Week 2 and Week 6

Secondary outcomes (2)

Connor-Davidson Resilience Scale (CD-RISC)
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).
Measured: Week 2 and Week 6
Beck Depression Inventory, Second Edition (BDI-II)
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).
Measured: Week 2 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Dec 2014

First posted21 Jun 2007 (estimated)
Study startMar 2007
Primary completionSep 2008
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00489866
Sponsor's protocol ID: VA IRB#01163
Status last verified: Mar 2015
First submitted: 20 Jun 2007
Last updated: 31 Mar 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aripiprazole Augmentation of Antidepressants in PTSD
ClinicalTrials.gov ID: NCT00489866
Acronym / sponsor ID: VA IRB#01163
Conditions: PTSD
Keywords: PTSD, Antidepressant, Aripiprazole, OEF, OIF
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Durham VA Medical CenterUS federal agency
Study start: Mar 2007
Primary completion: Sep 2008 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Jun 2007 (estimated)
Results: Posted 28 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aripiprazole	Experimental	Drug: Aripiprazole
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AripiprazoleAripiprazole: 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	Drug	Aripiprazole
PlaceboSame as active drug.	Drug	Placebo

Primary outcome

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.
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).
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)

2 secondary outcomes

Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Week 2 and Week 6
Beck Depression Inventory, Second Edition (BDI-II)
Time frame: Week 2 and Week 6

Results and safety

Results posted to the registry on 28 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole	7	5
Placebo	7	7

Primary outcome: Clinician Administered PTSD Scale (CAPS)

Time frame: Week 2 and Week 6. Mean (Standard Deviation). Unit: Units on a scale

Measure	PTSD Symptoms Aripiprazole Treated Group n = 7	PTSD Symptoms Placebo Treated Group n = 7
Value	18.6 (24.28)	9.58 (11.)

Population analysed: Analysis was intention to treat.

Primary outcome: Brief Assessment of Cognition in Affective Disorders (BAC-A)

Time frame: Week 2 and Week 6. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Cognitive Symptoms Aripiprazole Treated Group n = 7	Cognitive Symptoms PlaceboTreated Group n = 7
Value	-0.41 (1.23)	-0.14 (0.56)

Primary outcome: Positive and Negative Symptoms Scale (PANSS)

Time frame: Week 2 and Week 6. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Psychotic Symptoms Aripiprazole Treated Group n = 7	Psychotic Symptoms Placebo Treated Group n = 7
Value	2.57 (12.04)	-5.1 (7.31)

Population analysed: Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
Placebo	0 of 7 (0%)	6 of 7 (85.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for PTSD

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
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RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine E Marx, MD, MA principal investigator

Durham VAMC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aripiprazole in people with PTSD, run by Durham VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician Administered PTSD Scale (CAPS) (time frame: Week 2 and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00489866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.