Skip to main content
OpenTrials
Completed

NCT Number: NCT00292370

Quetiapine Augmentation for Treatment-resistant 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Combat Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham VA Medical Center, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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])
  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Open Label (OL) Paroxetine

Drug

Open-label Paroxetine

Other names: Paxil

Placebo

Drug

Double-blind placebo taken with OL paroxetine

Other names: sugar pill

Quetiapine

Drug

Double-blind quetiapine taken with OL paroxetine

Other names: Seroquel

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Change in CGI-I

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

    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.

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

    Time frame: Baseline (week 8) to Endpoint (week 16 or termination)

    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.

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

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

    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.

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

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

    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).

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

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

    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.

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

    Time frame: From Baseline (week 8) to Endpoint (week 16)

    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.

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

    Time frame: Baseline (week 8) to Endpoint (week 16 or termination)

    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).

  8. Change in Arizona Sexual Experience Scale (ASEX)

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

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • AstraZeneca

Registry information

Official study title

A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Feb 15, 2006
Registry last updated
Oct 16, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.