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Post-Traumatic Stress Disorder (PTSD) and Seroquel

Information source: Cambridge Health Alliance
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Traumatic Stress Disorder

Intervention: Seroquel (Drug)

Phase: N/A

Status: Completed

Sponsored by: Cambridge Health Alliance

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary outcome will be the change from baseline in PTSD symptomatology at the week 8 timepoint.

Secondary outcome: The secondary outcome will be the change from baseline in PTSD symptomatology at the Week 8 timepoint.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Central Street Health Center, Somerville, Massachusetts 02143, United States
Additional Information

Starting date: February 2010
Last updated: June 13, 2015

Page last updated: August 23, 2015

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