Post-Traumatic Stress Disorder (PTSD) and Seroquel

April 18, 2017 updated by: Igor Elman, Cambridge Health Alliance

Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Somerville, Massachusetts, United States, 02143
        • Central Street Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Investigators

  • Principal Investigator: Igor Elman, MD, CHA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-001664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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