Trial of Quetiapine in Anorexia Nervosa

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT00518973
Collaborator
University of South Florida (Other)
21
Enrollment
1
Location
2
Arms
46
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2006
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

ArmIntervention/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 Names:
  • Seroquel
  • Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UCSD Department of Psychiatry Center for Eating Disorder ResearchSan DiegoCaliforniaUnited States92037

    Sponsors and Collaborators

    • University of California, San Diego
    • University of South Florida

    Investigators

    • Principal Investigator: Walter Kaye, MD, University of California, San Diego and University of Pittsburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walter Kaye, Program Director and Professor of Psychiatry, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT00518973
    Other Study ID Numbers:
    • 051027
    • QUET0376
    First Posted:
    Aug 21, 2007
    Last Update Posted:
    Jul 17, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailOf these 21, 15 were randomized and began the drug; the other six participants failed the in-person screening phase.
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Period Title: Overall Study
    STARTED96
    COMPLETED64
    NOT COMPLETED32

    Baseline Characteristics

    Arm/Group TitlePlaceboQuetiapineTotal
    Arm/Group DescriptionSubjects 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.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.Total of all reporting groups
    Overall Participants9615
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    NA
    (NA)
    NA
    (NA)
    34
    (13.48)
    Sex: Female, Male (Count of Participants)
    Female
    NA
    NaN
    NA
    NaN
    NA
    NaN
    Male
    NA
    NaN
    NA
    NaN
    NA
    NaN
    Region of Enrollment (participants) [Number]
    United States
    9
    100%
    6
    100%
    15
    100%

    Outcome Measures

    1. Primary Outcome
    TitleHours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
    DescriptionThe YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.
    Time FrameDay 1 to LOCF (up to 8 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Measure Participants96
    Hours occupied by preoccupations
    NA
    (NA)
    NA
    (NA)
    Hours occupied by rituals
    NA
    (NA)
    NA
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.15
    Commentst = 2.8
    Methodt-test, 2 sided
    CommentsHours occupied by preoccupations.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.40
    Commentst = .56
    Methodt-test, 2 sided
    CommentsHours of rituals
    2. Primary Outcome
    TitleDifference in Scores on the EDI-2 (Eating Disorders Inventory)
    DescriptionThe EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears
    Time FrameDay 1 to LOCF (up to 8 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Measure Participants96
    Mean (Standard Deviation) [Units on the scale]
    NA
    (NA)
    NA
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.72
    Commentst = .13
    Methodt-test, 2 sided
    Comments
    3. Secondary Outcome
    TitleDifference in Scores on the STAI (State-Trait Anxiety Inventory)
    DescriptionThe State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
    Time FrameDay 1 to LOCF (up to 8 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Measure Participants96
    Trait
    NA
    (NA)
    NA
    (NA)
    State
    NA
    (NA)
    NA
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.48
    Commentst = .52
    Methodt-test, 2 sided
    CommentsReporting for Trait
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.77
    Commentst = .09
    Methodt-test, 2 sided
    CommentsReporting for State
    4. Secondary Outcome
    TitleDifferences in Scores on the HAM-D (Hamilton Depression Rating Scale)
    DescriptionHamilton 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 FrameDay 1 to LOCF (up to 8 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Measure Participants96
    Mean (Standard Deviation) [Units on the scale]
    NA
    (NA)
    NA
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.83
    Commentst = .05
    Methodt-test, 2 sided
    Comments
    5. Secondary Outcome
    TitleDifferences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
    DescriptionThe 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 FrameDay 1 to LOCF (up to 8 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    Measure Participants96
    Positive Scale
    NA
    (NA)
    NA
    (NA)
    Negative Scale
    NA
    (NA)
    NA
    (NA)
    General Scale
    NA
    (NA)
    NA
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.40
    Commentst = .78
    Methodt-test, 2 sided
    CommentsPositive Scale
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.11
    Commentst=3.0
    Methodt-test, 2 sided
    CommentsNegative Scale
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.90
    Commentst = .02
    Methodt-test, 2 sided
    CommentsGeneral Scale

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitlePlaceboQuetiapine
    Arm/Group DescriptionSubjects 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.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.
    All Cause Mortality
    PlaceboQuetiapine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/6 (0%)
    Serious Adverse Events
    PlaceboQuetiapine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/9 (11.1%) 2/6 (33.3%)
    Metabolism and nutrition disorders
    Worsening weight loss0/9 (0%) 01/6 (16.7%) 1
    Psychiatric disorders
    Worsening Manic Symptoms1/9 (11.1%) 10/6 (0%) 0
    Social circumstances
    Car Accident0/9 (0%) 01/6 (16.7%) 1
    Other (Not Including Serious) Adverse Events
    PlaceboQuetiapine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/6 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleWalter H. Kaye
    OrganizationUCSD Eating Disorders Treatment and Research Center
    Phone858-534-3951
    Emailwkaye@ucsd.edu
    Responsible Party:
    Walter Kaye, Program Director and Professor of Psychiatry, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT00518973
    Other Study ID Numbers:
    • 051027
    • QUET0376
    First Posted:
    Aug 21, 2007
    Last Update Posted:
    Jul 17, 2019
    Last Verified:
    Jun 1, 2019