Post-Traumatic Stress Disorder (PTSD) and Seroquel

• Sponsor: Cambridge Health Alliance (Other)
• Overall Status: Completed
• CT.gov ID: NCT01066156
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 60.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Drug: Seroquel	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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; Other Names: quetiapine

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. [8 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Central Street Health Center	Somerville	Massachusetts	United States	02143

Sponsors and Collaborators

• Cambridge Health Alliance

Investigators

• Principal Investigator: Igor Elman, MD, CHA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Igor Elman, MD, Cambridge Health Alliance
• ClinicalTrials.gov Identifier: NCT01066156
• Other Study ID Numbers: 2009-P-001664
• First Posted: Feb 10, 2010
• Last Update Posted: May 30, 2017
• Last Verified: Jun 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Igor Elman, MD, Cambridge Health Alliance: Post-traumatic Stress Disorder; PTSD; Seroquel; fMRI
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Quetiapine Fumarate

Study Results

Participant Flow

Arm/Group Title	Seroquel
Arm/Group Description	This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Period Title: Overall Study
STARTED	34
COMPLETED	24
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Seroquel
Arm/Group Description	This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	34 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.3 (8.3)
Sex: Female, Male (Count of Participants)
Female	16 47.1%
Male	18 52.9%
Region of Enrollment (Count of Participants)
United States	34 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).

Arm/Group Title	Seroquel
Arm/Group Description	This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Measure Participants	24
Mean (Standard Deviation) [units on a scale]	7.3 (18.5)

Adverse Events

Time Frame	4 years
Arm/Group Title	Seroquel
Arm/Group Description	This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
All Cause Mortality
	Seroquel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Seroquel
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Seroquel
	Affected / at Risk (%)	# Events
Total	0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.