Post-Traumatic Stress Disorder (PTSD) a… | Clinical Trial

Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Street Health Center

Somerville, Massachusetts, 02143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seroquel

Drug

This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Other names: quetiapine

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Feb 10, 2010
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed