Post-Traumatic Stress Disorder (PTSD) and Seroquel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Igor Elman, Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT01066156
First received: February 8, 2010
Last updated: June 13, 2015
Last verified: June 2015
  Purpose
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.

Condition Intervention
Post-Traumatic Stress Disorder
Drug: Seroquel

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:


Further study details as provided by Cambridge Health Alliance:

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 ]

Enrollment: 34
Study Start Date: February 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Central Street Health Center
Somerville, Massachusetts, United States, 02143
Sponsors and Collaborators
Cambridge Health Alliance
  More Information

Responsible Party: Igor Elman, MD, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT01066156     History of Changes
Other Study ID Numbers: 2009-P-001664 
Study First Received: February 8, 2010
Last Updated: June 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cambridge Health Alliance:
Post-traumatic Stress Disorder
PTSD
Seroquel
fMRI

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

ClinicalTrials.gov processed this record on July 27, 2016