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
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
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
NCT ID
NCT01066156
First Posted
February 8, 2010
Last Updated
April 18, 2017
Sponsor
Cambridge Health Alliance
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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