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Completed

NCT Number: NCT00518973

Trial of Quetiapine in Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Department of Psychiatry Center for Eating Disorder Research

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Seroquel

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.

Primary outcomes

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

    Time frame: Day 1 to LOCF (up to 8 weeks)

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

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

    Time frame: Day 1 to LOCF (up to 8 weeks)

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

Secondary outcomes

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

    Time frame: Day 1 to LOCF (up to 8 weeks)

    The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.

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

    Time frame: Day 1 to LOCF (up to 8 weeks)

    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.

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

    Time frame: Day 1 to LOCF (up to 8 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • University of South Florida

Registry information

Official study title

Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2007
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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