Quetiapine for Bipolar Disorder and Alcohol Dependence

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00457197
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Alcohol Dependence	Drug: Placebo; Drug: Quetiapine	Phase 4

Detailed Description

The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Quetiapine for Bipolar Disorder and Alcohol Dependence
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.	Drug: Placebo; Inactive ingredient matching the active medication in appearance.; Other Names: Sugar-pill
Active Comparator: Quetiapine This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.	Drug: Quetiapine; Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.; Other Names: Seroquel Xeroquel Ketipinor

Outcome Measures

Primary Outcome Measures

1. The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. [12 weeks]

Secondary Outcome Measures

1. Percent of Heavy Drinking Days [12 weeks]

2. Gamma-glutamyltransferase (GGT) [12 weeks]

   GGT is a liver enzyme measurement (IU/I)

3. Aspartate Aminotransferase (AST) [12 weeks]

   AST is a liver enzyme measurement (IU/I)

4. Alanine Aminotransferase (ALT) [12 weeks]

   ALT is a liver enzyme measurement (IU/I).

5. Hamilton Rating Scale for Depression (HRSD) [12 weeks]

   The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+). Scale: Minimum: 0 Maximum: 50 Lower score associated with better outcome

6. Inventory of Depressive Symptomatology-Self Report (IDS-SR) [12 weeks]

   IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome

7. Young Mania Rating Scale (YMRS) [12 weeks]

   This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome

8. Penn Alcohol Craving Scale (PACS) [12 weeks]

   The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking Score: Minimum: 0 Maximum: 30 Lower score associated with better outcome.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.

• Current diagnosis of alcohol dependence.

• Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.

• Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for > 14 days.

• Men and women age 18-65 years old.

• English or Spanish speaking.

Exclusion Criteria:

• Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.

• Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating Scale (HRSD) 17 score > 35.

• Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).

• Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of > 8.

• History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.

• Mental retardation or other severe cognitive impairment.

• Prison or jail inmates.

• Pregnant or nursing women or women of childbearing age who will not use oral contraceptives, abstinence, or other acceptable methods of birth control during the study.

• Antipsychotic therapy within 14 days prior to randomization.

• Current carbamazepine or benzodiazepine therapy.

• Current treatment with medications shown to reduce alcohol consumption (naltrexone, acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.

• Initiation of antidepressants or mood stabilizers or psychotherapy within past 2 weeks.

• High risk for suicide, defined as any suicide attempts in the past 3 months or current suicidal ideation with plan and intent.

• Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step programs or weekly psychotherapy that started at least 14 days prior to randomization will be allowed).

• Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.

• Severe or life-threatening medical condition (e.g., congestive heart failure, terminal cancer) or laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).

• Diabetes mellitus by history or suspected from baseline blood sugar.

• History of cataracts or suspected cataracts on ophthalmic exam

• History of seizure disorder of any etiology; if a subject develops a seizure episode, s/he will be discontinued from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychoneuroendocrine Research Program	Dallas	Texas	United States	75235

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: E. Sherwood Brown, MD PhD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT00457197
• Other Study ID Numbers: 112006-046
• First Posted: Apr 6, 2007
• Last Update Posted: Apr 5, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by University of Texas Southwestern Medical Center: bipolar disorder; alcohol dependence; mania; manic disorder; depression
• Additional relevant MeSH terms: Disease; Alcoholism; Bipolar Disorder; Quetiapine Fumarate

Study Results

Participant Flow

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Period Title: Overall Study
STARTED	45	45
COMPLETED	44	44
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Placebo	Quetiapine	Total
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.	Total of all reporting groups
Overall Participants	44	44	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.7 (10.1)	43.3 (8.2)	41.5 (9.2)
Sex: Female, Male (Count of Participants)
Female	19 43.2%	17 38.6%	36 40.9%
Male	25 56.8%	27 61.4%	52 59.1%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	21 47.7%	21 47.7%	42 47.7%
African American	12 27.3%	13 29.5%	25 28.4%
Hispanic	10 22.7%	7 15.9%	17 19.3%
Other	1 2.3%	2 4.5%	3 3.4%
Missing	0 0%	1 2.3%	1 1.1%
Married (participants) [Number]
Married	8 18.2%	10 22.7%	18 20.5%
Not Married	36 81.8%	34 77.3%	70 79.5%
Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.3 (2.4)	13.6 (2.5)	13.5 (2.5)
Mood states (participants) [Number]
Depressed	40 90.9%	38 86.4%	78 88.6%
Mixed (both depression and mania at same time)	4 9.1%	6 13.6%	10 11.4%
History of treatment for drug/alcohol (participants) [Number]
History	25 56.8%	30 68.2%	55 62.5%
No History	19 43.2%	14 31.8%	33 37.5%
% Days Alcohol Use In Past Week (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	74.6 (26.1)	74.2 (27.3)	74.4 (26.7)
% Days Heavy Alcohol Use In Past Week (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	60.0 (30.1)	53.0 (30.9)	56.5 (30.5)
Drinks per day (drinks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [drinks]	6.5 (3.4)	6.0 (3.4)	6.3 (3.4)
Liver enzymes (IU/I) [Mean (Standard Deviation) ]
GGT (gamma-glutamyltransferase	47.8 (37.6)	74.3 (69.3)	61.05 (53.45)
AST (aspartate aminotransferase)	27.4 (14.8)	29.7 (13.5)	28.6 (14.2)
ALT (alanine aminotransferase)	29.0 (24.5)	28.9 (17.3)	29.0 (20.9)
Concomitant medications (participants) [Number]
Lithium	28 63.6%	27 61.4%	55 62.5%
No Lithium	16 36.4%	17 38.6%	33 37.5%
Concomitant medications (participants) [Number]
Anticonvulsants	13 29.5%	13 29.5%	26 29.5%
No anticonvulsants	31 70.5%	31 70.5%	62 70.5%
Concomitant medications (participants) [Number]
Antidepressants	6 13.6%	11 25%	17 19.3%
No antidepressants	38 86.4%	33 75%	71 80.7%
Concomitant medications (participants) [Number]
Sedatives/hypnotics	2 4.5%	8 18.2%	10 11.4%
No sedatives/hypnotics	42 95.5%	36 81.8%	78 88.6%
Mood and craving scales: Hamilton Rating Scale for Depression (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.3 (6.7)	18.6 (7.0)	18.5 (6.9)
Mood and craving scales: Inventory of Depressive Symptomatology-Self-Report (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.6 (10.7)	33.9 (14.6)	31.3 (12.65)
Mood and craving scales: Young Mania Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.6 (8.2)	13.9 (6.7)	13.8 (7.5)
Mood and craving scales: Penn Alcohol Craving Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.2 (6.6)	20.6 (6.3)	19.9 (6.5)

Outcome Measures

1. Primary Outcome

Title	The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	44	44
Least Squares Mean (Standard Error) [drinks]	10.6 (2.465)	8.09 (2.465)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline drinks/day used as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4709
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Percent of Heavy Drinking Days
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	44	44
Least Squares Mean (Standard Error) [drinks]	28.8 (3.66)	20.8 (3.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline percent heavy drinking days included as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1272
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Gamma-glutamyltransferase (GGT)
Description	GGT is a liver enzyme measurement (IU/I)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	26	33
Least Squares Mean (Standard Error) [IU/I]	66.6 (8.34)	66.0 (7.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline GGT used as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9642
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Aspartate Aminotransferase (AST)
Description	AST is a liver enzyme measurement (IU/I)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	25	33
Least Squares Mean (Standard Error) [IU/I]	29.7 (2.92)	31.1 (2.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline AST used as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7222
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Alanine Aminotransferase (ALT)
Description	ALT is a liver enzyme measurement (IU/I).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	27	31
Least Squares Mean (Standard Error) [IU/I]	25.1 (2.61)	30.4 (2.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline ALT used as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1412
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Hamilton Rating Scale for Depression (HRSD)
Description	The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+). Scale: Minimum: 0 Maximum: 50 Lower score associated with better outcome
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	42	41
Least Squares Mean (Standard Error) [units on a scale]	10.9 (1.10)	10.3 (1.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline HRSD used as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7071
	Comments
	Method	ANCOVA
	Comments

7. Secondary Outcome

Title	Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Description	IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	40	42
Least Squares Mean (Standard Error) [units on a scale]	19.0 (1.79)	21.9 (1.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline IDS-SR used as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2569
	Comments
	Method	ANCOVA
	Comments

8. Secondary Outcome

Title	Young Mania Rating Scale (YMRS)
Description	This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	38	43
Least Squares Mean (Standard Error) [units on a scale]	8.70 (1.09)	8.48 (1.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline YMRS used as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8814
	Comments
	Method	ANCOVA
	Comments

9. Secondary Outcome

Title	Penn Alcohol Craving Scale (PACS)
Description	The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking Score: Minimum: 0 Maximum: 30 Lower score associated with better outcome.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.

Arm/Group Title	Placebo	Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.	This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Measure Participants	43	39
Least Squares Mean (Standard Error) [units on a scale]	14.1 (1.03)	12.3 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Quetiapine
	Comments	Baseline PACS used as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2473
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Arm/Group Title	Placebo		Quetiapine
Arm/Group Description	This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance.		This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
All Cause Mortality
	Placebo		Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/45 (6.7%)		5/45 (11.1%)
Cardiac disorders
Myocardial Infarction	0/45 (0%)		1/45 (2.2%)
Injury, poisoning and procedural complications
Fall	2/45 (4.4%)		0/45 (0%)
Victim of Sexual Assault	0/45 (0%)		1/45 (2.2%)
Psychiatric disorders
Arrest for Public Intoxication	1/45 (2.2%)		1/45 (2.2%)
Panic Attack	0/45 (0%)		1/45 (2.2%)
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation	0/45 (0%)		1/45 (2.2%)
Other (Not Including Serious) Adverse Events
	Placebo		Quetiapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)

Limitations/Caveats

Larger sample size possibly needed for between-group differences in outcome measures. Pill counts not an optimum measure of medication adherence.

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.