Trial of Quetiapine in Anorexia Nervosa

NCT00518973 | Completed Results

• 2 other identifiers: 051027QUET0376
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being held at UCSD to determine whether the medication Quetiapine helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This study will see if the medication Quetiapine helps symptoms of anxiety, depression, and obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and are currently suffering from anorexia nervosa are needed.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)

  The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.

  Day 1 to LOCF (up to 8 weeks)

• Difference in Scores on the EDI-2 (Eating Disorders Inventory)

  The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears

  Day 1 to LOCF (up to 8 weeks)

Secondary Outcomes (3)

• Difference in Scores on the STAI (State-Trait Anxiety Inventory)

  Day 1 to LOCF (up to 8 weeks)

• Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)

  Day 1 to LOCF (up to 8 weeks)

• Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)

  Day 1 to LOCF (up to 8 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The primary outcome was to determine the effect of quetiapine compared with placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorder Inventory-2 (EDI-2).

Drug: Placebo

Quetiapine

EXPERIMENTAL

Secondary outcomes were to determine if quetiapine is superior to placebo in reducing anxiety, depression and obsessionality assessed with the State Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM D) and Yale-Brown Obsessive Compulsive Scale, respectively. In addition, another secondary goal was to determine if quetiapine is superior to placebo in terms of weight gain. Adverse events were also determined.

Drug: Quetiapine

Interventions

Quetiapine DRUG

Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.

Also known as: Seroquel

Quetiapine

Placebo DRUG

Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.

Placebo

Eligibility Criteria

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

You may qualify if:

• Meet criteria for DSM-IV anorexia nervosa (restricting or binge-eating/purging types)
• At least 15% below ideal body weight
• Judged to be reliable to keep clinic visits and able to take all tests and examinations required by the protocol and be able to understand and decide whether or not to sign the Informed Consent.

You may not qualify if:

• Subjects will not be included in the study who present with any of the following:
• Schizophrenia or schizoaffective disorder (DSM-IV)
• Any ECG abnormality considered clinically significant by the investigator
• Subjects with liver enzymes elevated two times or more above normal
• Other laboratory abnormalities considered clinically significant by the investigator including laboratory deviations requiring acute medical intervention
• Pregnant women, women of childbearing potential not using medically accepted means of contraception (abstinence, IUD, birth control pills, barrier devices or implanted progesterone rods stabilized for at least three months), and lactating women
• Serious suicide risk
• Any medical condition that would preclude the outpatient treatment of anorexia nervosa or the use of quetiapine
• Organic brain disease
• History of severe allergies
• Multiple adverse drug reactions or known allergy to quetiapine
• Use of neuroleptic medications (except benzodiazepines) within 7 days preceding randomization
• History of alcohol or substance abuse disorder as defined in the DSM-IV within the past 3 months.

Sponsors & Collaborators

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

Study Sites (1)

UCSD Department of Psychiatry Center for Eating Disorder Research

San Diego, California, 92037, United States

Location

Related Publications (1)

• Powers PS, Klabunde M, Kaye W. Double-blind placebo-controlled trial of quetiapine in anorexia nervosa. Eur Eat Disord Rev. 2012 Jul;20(4):331-4. doi: 10.1002/erv.2169. Epub 2012 Apr 26.

  PMID: 22535517 RESULT

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Walter H. Kaye
• Organization: UCSD Eating Disorders Treatment and Research Center

wkaye@ucsd.edu

858-534-3951

Study Officials

• Walter Kaye, MD

  University of California, San Diego and University of Pittsburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director and Professor of Psychiatry

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 21, 2007
• Study Start: July 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Locations

US (1)