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Post-Traumatic Stress Disorder (PTSD) and Seroquel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Mclean Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01066156
First received: February 8, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

This 8 weeks study will investigate how brain activations in PTSD predict therapeutic responses to Seroquel XR pharmacotherapy.


Condition Intervention
Post-Traumatic Stress Disorder
 Drug: Seroquel XR

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • The primary outcome will be the change from baseline in PTSD symptomatology at the week 8 timepoint. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome will be the change from baseline in PTSD symptomatology at the Week 8 timepoint. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seroquel XR
This study will investigate how brain activations in PTSD predict therapeutic responses to Seroquel XR pharmacotherapy
 Drug: Seroquel XR
This study will investigate how brain activations in PTSD predict therapeutic responses to Seroquel XR pharmacotherapy

Detailed Description:

The eight week clinical trial of Seroquel XR in PTSD patients will be combined with fMRI experiments. Participants will be exposed to distinct types of stimuli, namely sets of aversive and pleasant pictures from the IAPS and noxious thermal sensations.

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 Mclean Institutional Review Board, 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 XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days. Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066156

Contacts
Contact: Evelyne Tschibelu, BS 617-855-3370 etschibelu@mclean.harvard.edu
Contact: Igor Elman, MD 617-855-3692 ielman@partners.org

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Evelyne Tschibelu, BS     617-855-3370     etschibelu@mclean.harvard.edu    
Contact: Igor Elman, MD     617-855-3692     ielman@partners.org    
Principal Investigator: Igor Elman, MD            
Sponsors and Collaborators
Mclean Hospital
  More Information

No publications provided

Responsible Party: Igor Elman/M.D., McLean Hospital
ClinicalTrials.gov Identifier: NCT01066156     History of Changes
Other Study ID Numbers: 2009-P-001664
Study First Received: February 8, 2010
Last Updated: February 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Post-traumatic Stress Disorder
PTSD
Seroquel
fMRI

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013