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Combat DisordersPhase 4NCT00292370

Quetiapine Augmentation for Treatment-resistant PTSD

A Phase 4 study testing Open Label (OL) Paroxetine and Quetiapine in people with Combat Disorders and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 3 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Open Label (OL) Paroxetine and Quetiapine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
3 sitesUnited States
Study dates
Jan 2006to May 2009
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran age 18 to 75.
  • Competent to give informed consent.
  • Meeting DSM-IV criteria for PTSD.
  • Minimal CAPS score of 50 at baseline.
  • If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.
  • Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine [5 weeks])
Show all 13Show fewer
  • monoamine oxidase inhibitors (MAOIs [4 weeks])
  • depot neuroleptics [4 weeks])
  • or any investigational drug within 30 days prior to study enrollment.
  • To be eligible for Phase II
  • patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
  • must have PTSD symptoms at least moderate severity on CGI-S
  • and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.

Who cannot join

  • History of sensitivity to paroxetine or quetiapine.
  • Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).
  • Women who are
  • breast-feeding
  • pregnant
  • expect to become pregnant during the course of the study
Show all 11Show fewer
  • or are sexually active and are not using a medically acceptable method of birth control.
  • Presence of clinically significant hepatic
  • cardiovascular
  • or other medical conditions that may prevent safe administration of paroxetine or quetiapine
  • or any other clinically significant unstable medical conditions.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233

  • Ralph H. Johnson

    Charleston, South Carolina, 29401-5799

  • Tuscaloosa VAMC

    Tuscaloosa, Alabama, 35404

Other trials in United States

About this study

Official title: A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.

Read the detailed description

This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.

In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

Being tested
Open Label (OL) Paroxetine, Placebo, Quetiapine
Keywords
Atypical Antipsychotics, Controlled Trial, Paroxetine, Quetiapine, Stress Disorders, Post-Traumatic, Treatment refractory, Treatment resistant
Medical subject headings
Combat Disorders, Stress Disorders, Post-Traumatic

What participants receive

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

  • Open Label (OL) ParoxetineDrug

    Also called Paxil

    Open-label Paroxetine

  • PlaceboDrug

    Also called sugar pill

    Double-blind placebo taken with OL paroxetine

  • QuetiapineDrug

    Also called Seroquel

    Double-blind quetiapine taken with OL paroxetine

Study groups in NCT00292370
Study groupRoleWhat they receive
Arm 1: Open Label (OL) ParoxetineOtherOpen-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.
Receives: Drug: Open Label (OL) Paroxetine
Arm 2 OL Paroxetine + DB PlaceboPlacebo comparatorIn Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.
Receives: Drug: Open Label (OL) Paroxetine; Drug: Placebo
Arm 3: OL Paroxetine + DB QuetiapineExperimentalIn Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Receives: Drug: Open Label (OL) Paroxetine; Drug: Quetiapine

What is being measured

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

  1. Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.

    The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.

    Measured: From baseline (week 8) to endpoint (week 16 or termination)

Secondary outcomes (8)

  1. Change in CGI-I

    Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.

    Measured: From Baseline (week 8) to Endpoint (week 16 or termination)

  2. Change in Mean PANSS Total and Subscores From Baseline to Endpoint

    Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms.

    Measured: Baseline (week 8) to Endpoint (week 16 or termination)

  3. Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores

    Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale.

    Measured: From Baseline (week 8) to Endpoint (week 16 or Termination)

  4. Change in Total Mean Davidson Trauma Scale (DTS)

    The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D).

    Measured: From Baseline (week 8) to Endpoint (week 16 or Termination)

  5. Change in Mean Q-LES-Q Score From Baseline to Endpoint.

    Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life.

    Measured: From Baseline (week 8) to Endpoint (week 16 or termination)

  6. Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.

    The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality.

    Measured: From Baseline (week 8) to Endpoint (week 16)

  7. Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.

    The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe).

    Measured: Baseline (week 8) to Endpoint (week 16 or termination)

  8. Change in Arizona Sexual Experience Scale (ASEX)

    The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.

    Measured: From Baseline (week 8) to Endpoint (week 16 or termination)

Timeline

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

  1. First posted15 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2008
  4. Study completionMay 2009

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00292370
Sponsor's protocol ID
CLIN-006-04F
Status last verified
Sep 2019
First submitted
13 Feb 2006
Last updated
16 Oct 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132-56. doi: 10.1002/da.1029.

    PubMed 11387733

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Open Label (OL) Paroxetine and Quetiapine in people with Combat Disorders and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 3 sites 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 13 inclusion and 11 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 1 Jul 2014). 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?

Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. (time frame: From baseline (week 8) to endpoint (week 16 or termination)). 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 NCT00292370, which also lists 1 linked publication.

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 16 Oct 2019.

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