Trial Outcomes & Findings for Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT) (NCT NCT03846505)

NCT ID: NCT03846505

Last Updated: 2025-02-21

Results Overview

Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes. Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 192 participants
• Primary outcome timeframe: Baseline to week 12
• Results posted on: 2025-02-21

Participant Flow

Participants were recruited through internet advertisements, clinician referrals, and flyers. Following preliminary eligibility screening, Identified Patients and partners completed private written informed and a baseline assessment separately for privacy. The baseline assessment included a history and physical (H&P) exam and a battery of standardized self-report and interview measures. Recruitment and enrollment occurred from May 2019 to April 2023.

Participants were 96 adult romantic couples (total N=192) where at least one partner met diagnostic criteria for Alcohol Use Disorder in the past 6 months.Couples were required to have been in their current relationship for at least 6 months. Participants who were taking psychotropic medications were required to be on a stable dose for 4 weeks before enrolling.

Participant milestones

Measure	Oxytocin A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.	Placebo A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Treatment Phase STARTED	98	94
Treatment Phase COMPLETED	78	78
Treatment Phase NOT COMPLETED	20	16
Completed Follow Up Phase (6-month) STARTED	78	78
Completed Follow Up Phase (6-month) COMPLETED	72	77
Completed Follow Up Phase (6-month) NOT COMPLETED	6	1

Reasons for withdrawal

Measure	Oxytocin A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.	Placebo A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Treatment Phase Withdrawal by Subject	9	11
Treatment Phase Lost to Follow-up	6	2
Treatment Phase Opted out of intervention but completed assessments	5	3
Completed Follow Up Phase (6-month) Lost to Follow-up	6	1

Baseline Characteristics

Identified Patient and Partner listed in individual rows.

Baseline characteristics by cohort

Measure	Oxytocin n=98 Participants A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.	Placebo n=94 Participants A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.	Total n=192 Participants Total of all reporting groups
Age, Continuous Identified Patient	38.9 years STANDARD_DEVIATION 11.8 • n=49 Participants • Identified Patient and Partner listed in individual rows.	43.3 years STANDARD_DEVIATION 12.6 • n=47 Participants • Identified Patient and Partner listed in individual rows.	41.1 years STANDARD_DEVIATION 12.2 • n=96 Participants • Identified Patient and Partner listed in individual rows.
Age, Continuous Partner	38.6 years STANDARD_DEVIATION 13.5 • n=49 Participants • Identified Patient and Partner listed in individual rows.	42.1 years STANDARD_DEVIATION 12 • n=47 Participants • Identified Patient and Partner listed in individual rows.	40.35 years STANDARD_DEVIATION 12.6 • n=96 Participants • Identified Patient and Partner listed in individual rows.
Sex: Female, Male Identified Patient · Female	12 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	14 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	26 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Sex: Female, Male Identified Patient · Male	37 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	33 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	70 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Sex: Female, Male Partner · Female	38 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	34 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	72 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Sex: Female, Male Partner · Male	11 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	13 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	24 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=98 Participants	7 Participants n=94 Participants	11 Participants n=192 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=98 Participants	87 Participants n=94 Participants	181 Participants n=192 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=98 Participants	0 Participants n=94 Participants	0 Participants n=192 Participants
Race (NIH/OMB) Identified Patient · American Indian or Alaska Native	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · Asian	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · Black or African American	3 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	2 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	5 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · White	44 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	43 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	87 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · More than one race	2 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	3 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Identified Patient · Unknown or Not Reported	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · American Indian or Alaska Native	1 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · Asian	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	1 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · Black or African American	1 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	2 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	3 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · White	45 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	41 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	86 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · More than one race	2 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	3 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	5 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.
Race (NIH/OMB) Partner · Unknown or Not Reported	0 Participants n=49 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=47 Participants • Identified Patient and Partner listed in individual rows.	0 Participants n=96 Participants • Identified Patient and Partner listed in individual rows.

PRIMARY outcome

Timeframe: Baseline to week 12

Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes.

Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month).

Outcome measures

Measure	Oxytocin n=49 Participants A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=47 Participants A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)	36.8 percentage of days abstinent for alcohol Interval 25.5 to 48.1	35.9 percentage of days abstinent for alcohol Interval 24.7 to 47.1

PRIMARY outcome

Timeframe: Baseline to week 12

Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning.

Outcome measures

Measure	Oxytocin n=49 Participants A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=47 Participants A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)	25.0 score on a scale Interval 23.8 to 26.2	25.0 score on a scale Interval 23.7 to 26.2

PRIMARY outcome

Timeframe: Baseline to week 12

Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (> 4 standard drinks for women or > 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes.

Outcome measures

Measure	Oxytocin n=49 Participants A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=47 Participants A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)	11.8 percentage of heavy drinking days Interval 2.3 to 21.2	9.9 percentage of heavy drinking days Interval 0.6 to 19.3

POST_HOC outcome

Timeframe: Baseline to week 12

Change in alcohol problem severity was measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. The AUDIT was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0 to 40, with scores of 15 or greater representing moderate to severe Alcohol Use Disorder (AUD).

Outcome measures

Measure	Oxytocin n=49 Participants A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=47 Participants A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Change in Alcohol Problem Severity - Measured by Alcohol Use Disorder Identification Test (AUDIT)	14.6 score on a scale Interval 12.9 to 16.4	13.1 score on a scale Interval 11.2 to 14.9

POST_HOC outcome

Timeframe: Baseline to week 12

Between-group differences in patients' outcomes based on partners' alcohol use disorder (AUD) status measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. Scores range from 0-40 on the AUDIT, with higher scores representing greater problems with alcohol use, and 15 or greater representing AUD.

Group differences in patient outcomes included percent days abstinent and percent days heaving drinking, measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview. Outcomes also included patients' relationship functioning, measured by the Dyadic Adjustment Scale-Short Form (DAS-7), a 7-item Likert-type self-report measure, and patients' alcohol problem severity, measured by the AUDIT, a 10-item Likert-type self-report measure.

DAS score ranges from 0 to 36, with a higher score indicating more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress.

Outcome measures

Measure	Oxytocin n=48 Participants A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=48 Participants A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT) Percent days abstinent	-0.03 Cohen's D	0.00 Cohen's D
Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT) Percent heavy drinking days	-0.13 Cohen's D	-0.39 Cohen's D
Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT) Relationship functioning	-0.04 Cohen's D	0.01 Cohen's D
Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT) Alcohol problem severity	-0.12 Cohen's D	-0.26 Cohen's D

Adverse Events

Oxytocin

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oxytocin n=98 participants at risk A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=94 participants at risk A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Cardiac disorders Stroke	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Surgical and medical procedures Appendectomy	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Surgical and medical procedures Hernia surgery	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Infections and infestations Sepsis	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Psychiatric disorders Suicide attempt	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Cardiac disorders Supraventricular tachycardia/arrhythmia	0.00% 0/98 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	1.1% 1/94 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Psychiatric disorders Inpatient alcohol detoxification	1.0% 1/98 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	0.00% 0/94 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Injury, poisoning and procedural complications Thoracic injury	1.0% 1/98 • Number of events 1 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	0.00% 0/94 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)

Other adverse events

Measure	Oxytocin n=98 participants at risk A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.	Placebo n=94 participants at risk A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Infections and infestations Coronavirus infections	4.1% 4/98 • Number of events 4 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	11.7% 11/94 • Number of events 11 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Gastrointestinal disorders Gastrointestinal discomfort	16.3% 16/98 • Number of events 22 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	8.5% 8/94 • Number of events 8 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Infections and infestations Viral upper respiratory tract infections	19.4% 19/98 • Number of events 19 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	16.0% 15/94 • Number of events 16 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Nervous system disorders Headache/Migraine	8.2% 8/98 • Number of events 11 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	4.3% 4/94 • Number of events 4 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Injury, poisoning and procedural complications Injury/Accident	10.2% 10/98 • Number of events 11 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	2.1% 2/94 • Number of events 4 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Respiratory, thoracic and mediastinal disorders Sinusitis	9.2% 9/98 • Number of events 10 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	5.3% 5/94 • Number of events 6 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
Infections and infestations Influenza	8.2% 8/98 • Number of events 8 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)	0.00% 0/94 • Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)

Additional Information

Stacey Sellers, Lab Manager

Medical University of South Carolina - Institute of Psychiatry

Phone: 8437925807

Email: sellersst@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place