Anorexia Nervosa
Conditions
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.
Interventions
DRUGQuetiapine
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.
DRUGPlacebo
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.
Sponsors
University of South Florida
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Of these 21, 15 were randomized and began the drug; the other six participants failed the in-person screening phase.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Quetiapine | Total |
|---|---|---|---|
| Age, Continuous | NA years | NA years | 34 years STANDARD_DEVIATION 13.48 |
| Region of Enrollment United States | 9 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 6 |
| other Total, other adverse events | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 1 / 9 | 2 / 6 |
Outcome results
Primary
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
Time frame: Day 1 to LOCF (up to 8 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Difference in Scores on the EDI-2 (Eating Disorders Inventory) | NA Units on the scale |
| Quetiapine | Difference in Scores on the EDI-2 (Eating Disorders Inventory) | NA Units on the scale |
p-value: 0.72t-test, 2 sided
Primary
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.
Time frame: Day 1 to LOCF (up to 8 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) | Hours occupied by preoccupations | NA Hours |
| Placebo | Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) | Hours occupied by rituals | NA Hours |
| Quetiapine | Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) | Hours occupied by preoccupations | NA Hours |
| Quetiapine | Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) | Hours occupied by rituals | NA Hours |
p-value: 0.15t-test, 2 sided
p-value: 0.4t-test, 2 sided
Secondary
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.
Time frame: Day 1 to LOCF (up to 8 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Difference in Scores on the STAI (State-Trait Anxiety Inventory) | Trait | NA Units on the scale |
| Placebo | Difference in Scores on the STAI (State-Trait Anxiety Inventory) | State | NA Units on the scale |
| Quetiapine | Difference in Scores on the STAI (State-Trait Anxiety Inventory) | Trait | NA Units on the scale |
| Quetiapine | Difference in Scores on the STAI (State-Trait Anxiety Inventory) | State | NA Units on the scale |
p-value: 0.48t-test, 2 sided
p-value: 0.77t-test, 2 sided
Secondary
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.
Time frame: Day 1 to LOCF (up to 8 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Differences in Scores on the HAM-D (Hamilton Depression Rating Scale) | NA Units on the scale |
| Quetiapine | Differences in Scores on the HAM-D (Hamilton Depression Rating Scale) | NA Units on the scale |
p-value: 0.83t-test, 2 sided
Secondary
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.
Time frame: Day 1 to LOCF (up to 8 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | Positive Scale | NA Units on the scale |
| Placebo | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | Negative Scale | NA Units on the scale |
| Placebo | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | General Scale | NA Units on the scale |
| Quetiapine | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | Positive Scale | NA Units on the scale |
| Quetiapine | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | Negative Scale | NA Units on the scale |
| Quetiapine | Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale) | General Scale | NA Units on the scale |
p-value: 0.4t-test, 2 sided
p-value: 0.11t-test, 2 sided
p-value: 0.9t-test, 2 sided