Generalized Anxiety and Seroquel (GAD)

This study has been terminated.
(The underwriter stopped the funding)
Sponsor:
Information provided by (Responsible Party):
Igor Elman, MD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01066143
First received: February 8, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.


Condition Intervention
Generalized Anxiety Disorder
Seroquel XR
Drug: Seroquel XR

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • The primary outcome will be the change from baseline in GAD symptomatology at the Week 12 timepoint. [ Time Frame: 12 week ] [ Designated as safety issue: No ]
  • Change from baseline GAD symptomatology at the Week 12 timepoint. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seroquel XR Drug: Seroquel XR
Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Detailed Description:

Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Fluency in English
  • A diagnosis of GAD
  • No pregnancy
  • Right-handedness
  • Psychotropic medication-free at the start of the study

Exclusion Criteria:

  • Pregnancy or lactation
  • Any current DSM-IV-TR Axis I disorder
  • Any mental retardation or cognitive impairment that precludes informed consent
  • Known intolerance or lack of response to quetiapine fumarate
  • Substance or alcohol dependence at enrollment
  • Participation in another drug trial within 4 weeks prior enrollment
  • History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
  • History of prior Seroquel or other antipsychotic agents use
  • Contraindications to magnetic resonance imaging
  • Treatment with an effective medication for GAD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066143

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
  More Information

No publications provided

Responsible Party: Igor Elman, MD, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01066143     History of Changes
Other Study ID Numbers: 2009-P-001662
Study First Received: February 8, 2010
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Seroquel
Generalized Anxiety Disorder
fMRI

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014