Post-Traumatic Stress Disorder (PTSD) and Seroquel

NCT ID: NCT01066156

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-03-31

Brief Summary

This 8 weeks 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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seroquel

This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Group Type: EXPERIMENTAL

Seroquel

Intervention Type: DRUG

This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Interventions

Seroquel

This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Intervention Type: DRUG

Other Intervention Names

quetiapine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge Health Alliance

OTHER

Sponsor Role: lead

Responsible Party

Igor Elman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Igor Elman, MD

Role: PRINCIPAL_INVESTIGATOR

CHA

Locations

Central Street Health Center

Somerville, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-001664

Identifier Type: -

Identifier Source: org_study_id