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)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.5

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 Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Drug: Quetiapine; Drug: Placebo	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

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 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

	Site	City	State	Country	Postal Code
1	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

• 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: Anorexia; Anorexia Nervosa; Quetiapine Fumarate

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Placebo	Quetiapine	Total
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 Participants	9	6	15
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

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
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.
Measure Participants	9	6
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 Hypothesis	p-Value	.15
	Comments	t = 2.8
	Method	t-test, 2 sided
	Comments	Hours occupied by preoccupations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments
	Type of Statistical Test	Superiority
	Comments
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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
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.
Measure Participants	9	6
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 Hypothesis	p-Value	.72
	Comments	t = .13
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
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.
Measure Participants	9	6
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 Hypothesis	p-Value	.48
	Comments	t = .52
	Method	t-test, 2 sided
	Comments	Reporting for Trait

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments
	Type of Statistical Test	Superiority
	Comments
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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
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.
Measure Participants	9	6
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 Hypothesis	p-Value	.83
	Comments	t = .05
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
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.
Measure Participants	9	6
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 Hypothesis	p-Value	.40
	Comments	t = .78
	Method	t-test, 2 sided
	Comments	Positive Scale

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.11
	Comments	t=3.0
	Method	t-test, 2 sided
	Comments	Negative Scale

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.90
	Comments	t = .02
	Method	t-test, 2 sided
	Comments	General Scale

Adverse Events

Arm/Group Title	Placebo		Quetiapine
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/6 (0%)
Serious Adverse Events
	Placebo		Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		2/6 (33.3%)
Metabolism and nutrition disorders
Worsening weight loss	0/9 (0%)	0	1/6 (16.7%)	1
Psychiatric disorders
Worsening Manic Symptoms	1/9 (11.1%)	1	0/6 (0%)	0
Social circumstances
Car Accident	0/9 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (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.