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Trial of Quetiapine in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Sites / Locations

  • UCSD Department of Psychiatry Center for Eating Disorder Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Quetiapine

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Difference in Scores on the STAI (State-Trait Anxiety Inventory)
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
Hamilton Depression Rating Scale (HAM-D) form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A clinical interview is conducted and patient is rated from 1 to 7 on 30 different symptoms based on the interview.

Full Information

First Posted
August 20, 2007
Last Updated
June 24, 2019
Sponsor
University of California, San Diego
Collaborators
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00518973
Brief Title
Trial of Quetiapine in Anorexia Nervosa
Official Title
Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
Description
The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.
Time Frame
Day 1 to LOCF (up to 8 weeks)
Title
Difference in Scores on the EDI-2 (Eating Disorders Inventory)
Description
The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears
Time Frame
Day 1 to LOCF (up to 8 weeks)
Secondary Outcome Measure Information:
Title
Difference in Scores on the STAI (State-Trait Anxiety Inventory)
Description
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
Time Frame
Day 1 to LOCF (up to 8 weeks)
Title
Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
Description
Hamilton Depression Rating Scale (HAM-D) form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.
Time Frame
Day 1 to LOCF (up to 8 weeks)
Title
Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
Description
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A clinical interview is conducted and patient is rated from 1 to 7 on 30 different symptoms based on the interview.
Time Frame
Day 1 to LOCF (up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Kaye, MD
Organizational Affiliation
University of California, San Diego and University of Pittsburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Department of Psychiatry Center for Eating Disorder Research
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22535517
Citation
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.
Results Reference
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Trial of Quetiapine in Anorexia Nervosa

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