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Post-Traumatic Stress Disorder (PTSD) and Seroquel

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seroquel
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Street Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Seroquel

Arm Description

This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Outcomes

Primary Outcome Measures

Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2010
Last Updated
April 18, 2017
Sponsor
Cambridge Health Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT01066156
Brief Title
Post-Traumatic Stress Disorder (PTSD) and Seroquel
Official Title
Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge Health Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seroquel
Arm Type
Experimental
Arm Description
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Intervention Type
Drug
Intervention Name(s)
Seroquel
Other Intervention Name(s)
quetiapine
Intervention Description
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Primary Outcome Measure Information:
Title
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Elman, MD
Organizational Affiliation
CHA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Street Health Center
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-Traumatic Stress Disorder (PTSD) and Seroquel

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