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OpenTrials
Completed

NCT Number: NCT01066156

Post-Traumatic Stress Disorder (PTSD) and Seroquel

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

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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

  1. 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

Interested in participating?

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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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