A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study

NCT00584688 | Terminated Phase 2 DMC

• 1 other identifier: 0825
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.

Conditions

Anorexia Nervosa

Keywords

anorexia; nervosa; eating; disorder; study; research; clinical; trial; psychiatry; psychiatric

Outcome Measures

Primary Outcomes (1)

• To determine efficacy of seroquel in anorexia nervosa

  8 weeks

Interventions

quetiapine DRUG

quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be aged 18-65
• Must be at least 15% below ideal body weight

You may not qualify if:

• Allergy to quetiapine
• Diagnosis of schizophrenia

Sponsors & Collaborators

• University of South Florida: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of South Floirda

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia; Disease

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 18, 2012

Record last verified: 2009-03

Locations

US (1)