Post-Traumatic Stress Disorder (PTSD) and Seroquel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066156
Recruitment Status : Completed
First Posted : February 10, 2010
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Igor Elman, Cambridge Health Alliance

Brief Summary:
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: Seroquel Not Applicable

Detailed Description:
An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
Study Start Date : February 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Seroquel
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Drug: Seroquel
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Other Name: quetiapine

Primary Outcome Measures :
  1. Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. [ Time Frame: 8 weeks ]

    We will compare patients' symptomatology at baseline vs. at 8 week timepoint

    Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)

    Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136

    For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst

    If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provision of written informed consent
  • Fluency in English
  • A diagnosis of PTSD
  • No pregnancy
  • Right-handedness

Exclusion Criteria:

  • Pregnancy or lactation
  • Any cognitive impairment that precludes informed consent
  • Known intolerance or lack of response to Seroquel
  • Previous enrollment or randomization of treatment in the present study
  • Participation in another drug trial within 4 weeks prior enrollment into this study
  • Patients with Diabetes Mellitus
  • History of allergic reaction or hypersensitivity to Seroquel
  • Contraindications to magnetic resonance imaging
  • Treatment with an effective medication for PTSD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066156

United States, Massachusetts
Central Street Health Center
Somerville, Massachusetts, United States, 02143
Sponsors and Collaborators
Cambridge Health Alliance
Principal Investigator: Igor Elman, MD CHA

Responsible Party: Igor Elman, MD, Cambridge Health Alliance Identifier: NCT01066156     History of Changes
Other Study ID Numbers: 2009-P-001664
First Posted: February 10, 2010    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Igor Elman, Cambridge Health Alliance:
Post-traumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs