Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT00880919
• Collaborator: AstraZeneca (Industry), University of Iowa (Other), Mclean Hospital (Other)
• Enrollment: 95
• Locations: 3
• Arms: 3
• Duration (Months): 57
• Patients Per Site: 31.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD.

To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Drug: quetiapine extended-release; Drug: Placebo	Phase 3

Detailed Description

The secondary objectives in this study are aimed at answering further questions regarding symptom assessments, dosing strategies, and safety. The specific secondary objectives are listed below:

1. Response rate: In previous studies using the ZAN-BPD, response was defined as a 50% reduction of ZAN-BPD scores. Response rates will be compared between Seroquel XR and placebo.

2. Other Symptom Measures: Over the last twenty years, other rating scales of a general nature have been used to assess BPD patients in clinical trials. To fully assess the patients as they progress through the study, the following scales will be administered: Symptom Checklist 90 - Revised (SCL-90 R), Montgomery Asberg Depression Rating Scale (MADRS), Barratt Impulsivity Scale (BIS), Schedule for Interviewing Borderlines (SIB), Overt Aggression Scale - Modified (OAS-M), Young Mania Rating Scale (YMRS), the Borderline Evaluation of Severity over Time (BEST), and the Global Assessment of Function (GAF).

3. Side-Effects: To be able to report the safety of Seroquel XR for BPD, a combination of objective and subjective measures will be employed. Objectively, weight, height (and Body Mass Index (BMI)), prolactin, glucose, cholesterol and triglycerides will be assessed at baseline and endpoint. Objective ratings of movement side effects will be performed using Simpson Angus Scale (SAS) (Simpson and Angus 1970), Barnes Akathisia Scale (BAS) (Barnes 1989), and Abnormal Involuntary Movement Scale (AIMS) (Guy 1976), and at baseline and endpoint. Regarding possible side effects reported by patients, their reports of headache, somnolence, and other experiences will be tabulated.

Secondary objective data will be analyzed as continuous variable data over the time of the study or, when appropriate, comparisons of baseline to endpoint will be made.

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Seroquel XR for the Management of Borderline Personality Disorder (BPD)
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Drug: quetiapine extended-release; Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo; Other Names: Seroquel XR
Active Comparator: 2 Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Drug: quetiapine extended-release; Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo; Other Names: Seroquel XR
Placebo Comparator: 3 Equivalent number of placebo oral tablets taken daily for 8 weeks.	Drug: Placebo; Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo; Other Names: quetiapine extended-release

Outcome Measures

Primary Outcome Measures

1. Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) [baseline, weekly until week 8]

   This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.

2. Montgomery-Åsberg Depression Rating Scale (MADRS) [baseline to 8 weeks]

   Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.

3. Borderline Evaluation of Severity Over Time (BEST) [Baseline to 8 weeks]

   Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).

4. Overt Aggression Scale - Modified (OAS-M) [Change from Baseline Overt Aggression Scale - Modified to 8 weeks]

   Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.

5. Global Assessment of Functioning Scale (GAF) [Change in Global Assessment of Functioning from Baseline to 8 weeks]

   Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional

6. Barratt Impulsiveness Scale (BIS) [Change in Impulsiveness from Baseline to 8 weeks]

   30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.

7. Symptom Checklist -90-Revised (SCL-90-R) [Change in psychological problems and symptoms from Baseline to 8 weeks]

   90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms

8. Young Mania Rating Scale (YMS) [Change in manic symptoms from Baseline to 8 weeks]

   Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms

9. Sheehan Disability Scale (SDS) [Change in functional impairment from Baseline to 8 weeks]

   Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Consent

• A diagnosis of borderline personality disorder (301.83)

• All subjects will have a ZAN-BPD greater or equal to 9 at randomization.

• Males and females aged 18-45 years

• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment

• Able to understand and comply with the requirements of the study

Exclusion Criteria:

• Pregnancy or lactation

• Any DSM-IV Axis I disorder not defined in the inclusion criteria. The patients with BPD may not have bipolar I disorder, schizophrenia, schizoaffective disorder, delirium, or dementia. Neither may they have current DSM-IV substance dependence.

• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

• Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator

• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir

• Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids

• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization

• Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment

• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment

• Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension, congestive heart failure) as judged by the investigator

• Involvement in the planning and conduct of the study

• Previous enrollment or randomization of treatment in the present study.

• Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements

• Unstable Diabetes Mellitus

• An absolute neutrophil count (ANC) of 1.5 x 109 per liter

• Past history of lack of response to an atypical antipsychotic medication or substantial previous side effects will be cause for exclusion.

• Any medical illness that would interfere with conduct of the study will be cause for exclusion.

• Pregnant or lactating women and women of childbearing potential not using medically accepted means of contraception.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa, Department of Psychiatry	Iowa City	Iowa	United States	52242
2	McLean Hospital, Harvard Medical School, Department of Psychiatry	Belmont	Massachusetts	United States	02478
3	University of Minnesota Medical Center, Fairview Riverside	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota
• AstraZeneca
• University of Iowa
• Mclean Hospital

Investigators

• Principal Investigator: S. Charles Schulz, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00880919
• Other Study ID Numbers: 0709M16844; IRUSQUET0454
• First Posted: Apr 14, 2009
• Last Update Posted: Mar 9, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Minnesota: Borderline Personality Disorder; BPD; Seroquel; Seroquel XR; quetiapine; quetiapine extended-release
• Additional relevant MeSH terms: Disease; Personality Disorders; Borderline Personality Disorder; Quetiapine Fumarate

Study Results

Participant Flow

Recruitment Details	This randomized, double-blind, placebo-controlled, dose comparison trial was conducted at three outpatient treatment centers from January 2010 to March 2013.
Pre-assignment Detail	Ninety-five persons with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) borderline personality disorder (BPD) were randomly assigned to quetiapine XR 150 mg/day (n=33), quetiapine XR 300 mg/day (n=33), or placebo (n=29).

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Period Title: Overall Study
STARTED	33	33	29
COMPLETED	18	19	23
NOT COMPLETED	15	14	6

Baseline Characteristics

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).	Total
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.	Total of all reporting groups
Overall Participants	33	33	29	95
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	33 100%	33 100%	29 100%	95 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.2 (8.0)	30.2 (8.1)	20.1 (8.8)	29.5 (8.3)
Sex: Female, Male (Count of Participants)
Female	25 75.8%	23 69.7%	19 65.5%	67 70.5%
Male	8 24.2%	10 30.3%	10 34.5%	28 29.5%
Region of Enrollment (participants) [Number]
United States	33 100%	33 100%	29 100%	95 100%

Outcome Measures

1. Primary Outcome

Title	Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
Description	This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
Time Frame	baseline, weekly until week 8

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Deviation) [units on a scale]	-1.22 (0.15)	-0.99 (0.16)	-0.75 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Quetiapine XR 150 mg/Day (n=33),, Quetiapine XR 300 mg/Day (n=33),, Placebo (n=29).
	Comments	Mean changes were calculated using each groups linear and quadratic effects
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.015
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Montgomery-Åsberg Depression Rating Scale (MADRS)
Description	Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.
Time Frame	baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33)	Quetiapine XR 300 mg/Day (n=33)	Placebo (n=29)
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks. quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo	Seroquel XR 300mg oral tablets taken daily for 8 weeks. quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo	Equivalent number of placebo oral tablets taken daily for 8 weeks. Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-0.85 (0.19)	-1.05 (0.19)	-0.59 (0.18)

3. Primary Outcome

Title	Borderline Evaluation of Severity Over Time (BEST)
Description	Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-2.10 (0.32)	-1.97 (0.33)	-0.91 (0.31)

4. Primary Outcome

Title	Overt Aggression Scale - Modified (OAS-M)
Description	Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.
Time Frame	Change from Baseline Overt Aggression Scale - Modified to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-1.92 (0.42)	-1.82 (0.43)	-0.37 (0.43)

5. Primary Outcome

Title	Global Assessment of Functioning Scale (GAF)
Description	Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional
Time Frame	Change in Global Assessment of Functioning from Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	1.05 (0.20)	1.04 (0.21)	0.62 (0.19)

6. Primary Outcome

Title	Barratt Impulsiveness Scale (BIS)
Description	30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.
Time Frame	Change in Impulsiveness from Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-0.73 (0.27)	-0.83 (0.27)	-.59 (0.26)

7. Primary Outcome

Title	Symptom Checklist -90-Revised (SCL-90-R)
Description	90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms
Time Frame	Change in psychological problems and symptoms from Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-0.11 (0.02)	-0.12 (0.02)	-0.07 (0.02)

8. Primary Outcome

Title	Young Mania Rating Scale (YMS)
Description	Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms
Time Frame	Change in manic symptoms from Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-0.26 (0.06)	-0.30 (0.06)	0.11 (0.06)

9. Primary Outcome

Title	Sheehan Disability Scale (SDS)
Description	Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment
Time Frame	Change in functional impairment from Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.

Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),	Quetiapine XR 300 mg/Day (n=33),	Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.	Seroquel XR 300mg oral tablets taken daily for 8 weeks.	Equivalent number of placebo oral tablets taken daily for 8 weeks.
Measure Participants	33	33	29
Mean (Standard Error) [units on a scale]	-0.85 (0.19)	-1.11 (0.20)	0.58 (0.18)

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Quetiapine XR 150 mg/Day (n=33),		Quetiapine XR 300 mg/Day (n=33),		Placebo (n=29).
Arm/Group Description	Seroquel XR 150mg oral tablets taken daily for 8 weeks.		Seroquel XR 300mg oral tablets taken daily for 8 weeks.		Equivalent number of placebo oral tablets taken daily for 8 weeks.
All Cause Mortality
	Quetiapine XR 150 mg/Day (n=33),		Quetiapine XR 300 mg/Day (n=33),		Placebo (n=29).
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Quetiapine XR 150 mg/Day (n=33),		Quetiapine XR 300 mg/Day (n=33),		Placebo (n=29).
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Quetiapine XR 150 mg/Day (n=33),		Quetiapine XR 300 mg/Day (n=33),		Placebo (n=29).
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/33 (87.9%)		30/33 (90.9%)		19/29 (65.5%)
Gastrointestinal disorders
Nausea or vomiting	4/33 (12.1%)	4	4/33 (12.1%)	4	4/29 (13.8%)	4
General disorders
Dry mouth	9/33 (27.3%)	9	14/33 (42.4%)	14	1/29 (3.4%)	1
Headache	7/33 (21.2%)	7	10/33 (30.3%)	10	6/29 (20.7%)	6
Hypersomnia	5/33 (15.2%)	5	8/33 (24.2%)	8	2/29 (6.9%)	2
Dizziness	5/33 (15.2%)	5	7/33 (21.2%)	7	1/29 (3.4%)	1
Metabolism and nutrition disorders
Change in appetite	9/33 (27.3%)	9	12/33 (36.4%)	12	4/29 (13.8%)	4
Musculoskeletal and connective tissue disorders
Bodily pain	6/33 (18.2%)	6	9/33 (27.3%)	9	5/29 (17.2%)	5
Nervous system disorders
Sedation	29/33 (87.9%)	29	30/33 (90.9%)	30	19/29 (65.5%)	19
Forgetfulness or confusion	5/33 (15.2%)	5	7/33 (21.2%)	7	1/29 (3.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.