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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Anorexia Nervosa
Interventions Drug: Quetiapine
Drug: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details Of these 21, 15 were randomized and began the drug; the other six participants failed the in-person screening phase.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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. 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
Started 9 6
Completed 6 4
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             3             2
Arm/Group Title Placebo Quetiapine Total
Hide Arm/Group 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. 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 Number of Baseline Participants 9 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 15 participants
NA [1]   (NA) NA [1]   (NA) 34  (13.48)
[1]
The data is not available
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female NA [1]  NA [1]  NA [2] 
Male NA [1]  NA [1]  NA [2] 
[1]
Data not available
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 6 participants 15 participants
9 6 15
1.Primary Outcome
Title Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: Hours
Hours occupied by preoccupations NA [1]   (NA) NA [1]   (NA)
Hours occupied by rituals NA [1]   (NA) NA [1]   (NA)
[1]
Access to raw data is not available, only the statistical analysis from the publication are available.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments t = 2.8
Method t-test, 2 sided
Comments Hours occupied by preoccupations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .40
Comments t = .56
Method t-test, 2 sided
Comments Hours of rituals
2.Primary Outcome
Title Difference in Scores on the EDI-2 (Eating Disorders Inventory)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: Units on the scale
NA [1]   (NA) NA [1]   (NA)
[1]
Access to raw data is not available, only the statistical analysis from the publication are available.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .72
Comments t = .13
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Difference in Scores on the STAI (State-Trait Anxiety Inventory)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: Units on the scale
Trait NA [1]   (NA) NA [1]   (NA)
State NA [1]   (NA) NA [1]   (NA)
[1]
Access to raw data is not available, only the statistical analysis from the publication are available.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .48
Comments t = .52
Method t-test, 2 sided
Comments Reporting for Trait
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .77
Comments t = .09
Method t-test, 2 sided
Comments Reporting for State
4.Secondary Outcome
Title Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: Units on the scale
NA [1]   (NA) NA [1]   (NA)
[1]
Access to raw data is not available, only the statistical analysis from the publication are available.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .83
Comments t = .05
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: Units on the scale
Positive Scale NA [1]   (NA) NA [1]   (NA)
Negative Scale NA [1]   (NA) NA [1]   (NA)
General Scale NA [1]   (NA) NA [1]   (NA)
[1]
Access to raw data is not available, only the statistical analysis from the publication are available.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .40
Comments t = .78
Method t-test, 2 sided
Comments Positive Scale
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .11
Comments t=3.0
Method t-test, 2 sided
Comments Negative Scale
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .90
Comments t = .02
Method t-test, 2 sided
Comments General Scale
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Quetiapine
Hide Arm/Group 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. 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
Placebo Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      2/6 (33.33%)    
Metabolism and nutrition disorders     
Worsening weight loss [1]  0/9 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders     
Worsening Manic Symptoms [2]  1/9 (11.11%)  1 0/6 (0.00%)  0
Social circumstances     
Car Accident [3]  0/9 (0.00%)  0 1/6 (16.67%)  1
[1]
Participant was hospitalized for worsening weight loss
[2]
Participant was hospitalized for worsening manic symptoms.
[3]
Participant was hospitalized after she was hit by a car while riding a bicycle.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/6 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Walter H. Kaye
Organization: UCSD Eating Disorders Treatment and Research Center
Phone: 858-534-3951
EMail: wkaye@ucsd.edu
Layout table for additonal information
Responsible Party: Walter Kaye, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00518973     History of Changes
Other Study ID Numbers: 051027
QUET0376
First Submitted: August 20, 2007
First Posted: August 21, 2007
Results First Submitted: June 24, 2019
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019