Post-Traumatic Stress Disorder (PTSD) and Seroquel

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066156
• Other study ID #: 2009-P-001664
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: June 13, 2015
• Start date: February 2010
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Seroquel
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Locations

Country	Name	City	State
United States	Central Street Health Center	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Health Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the change from baseline in PTSD symptomatology at the week 8 timepoint.		8 weeks	No
Secondary	The secondary outcome will be the change from baseline in PTSD symptomatology at the Week 8 timepoint.		8 weeks	No