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Trial record 45 of 450 for:    QUETIAPINE

Trial of Quetiapine in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT00518973
Recruitment Status : Completed
First Posted : August 21, 2007
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Walter Kaye, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Quetiapine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
Study Start Date : July 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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
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.

Experimental: Quetiapine
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
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 Name: Seroquel




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518973


Locations
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United States, California
UCSD Department of Psychiatry Center for Eating Disorder Research
San Diego, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
University of South Florida
Investigators
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Principal Investigator: Walter Kaye, MD University of California, San Diego and University of Pittsburg

Publications of Results:
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Responsible Party: Walter Kaye, Program Director and Professor of Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00518973     History of Changes
Other Study ID Numbers: 051027
QUET0376
First Posted: August 21, 2007    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Quetiapine Fumarate
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs