Trial Outcomes & Findings for Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD) (NCT NCT03757585)

Last Updated: 2025-06-05

Results Overview

The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. The YMRS score ranges from 0-60. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania. Higher scores indicate more severe manic symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

Baseline to 6 Weeks

Results posted on

2025-06-05

Participant Flow

We will use advertisements on the Internet, including advertisements posted on the Partners Clinical trials website, and flyers to recruit participants. Individuals who respond to advertising will go through a phone screen with the study coordinator or research assistant via phone and will then be screened by a study clinician.

Participants may also be recruited from the referral pool of existing and new patients in the Pediatric Psychopharmacology Program and the MGH Child Psychiatry Outpatient Clinic or from the pool of children screened for participation in Protocol #2019-P-000846 ("An Open-Label Clinical Trial Conducted via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth").

Participant milestones

Participant milestones
Measure	Omega-3 Fatty Acids + Inositol Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD).	N-acetylcysteine Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg QD) based on age.
Overall Study STARTED	27	27
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega-3 Fatty Acid Plus Inositol n=27 Participants Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=27 Participants Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 Weeks

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acid Plus Inositol n=18 Participants Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=19 Participants Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score	0.0 Units on a Scale Standard Deviation 7.9	-2.6 Units on a Scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: Baseline to 6 Weeks

The CDI consists of 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; parents select the one that characterized their child's symptoms best during the past 1 week. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acid Plus Inositol n=18 Participants Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=19 Participants Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.
Mean Change in the Parent-completed Children's Depression Inventory (CDI)	-3.4 Units on a Scale Standard Deviation 7.7	-1.3 Units on a Scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline to 6 Weeks

The CGI-BPD-S is a clinician-rated measure of bipolar disorder severity. Severity scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The outcome reported reflects the change from baseline in CGI-BPD-S scores and negative scores represent improvement (i.e., decrease in severity from baseline).

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acid Plus Inositol n=18 Participants Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=19 Participants Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.
Mean Change in the NIMH Clinical Global Improvement Scale (CGI)	-1.1 Units on a Scale Standard Deviation 1.3	-0.7 Units on a Scale Standard Deviation 1.1

Adverse Events

Omega-3 Fatty Acid Plus Inositol

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

N-Acetylcysteine

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omega-3 Fatty Acid Plus Inositol n=27 participants at risk Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=27 participants at risk Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.
Psychiatric disorders Depression	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.

Other adverse events

Other adverse events
Measure	Omega-3 Fatty Acid Plus Inositol n=27 participants at risk Subjects randomized to receive omega-3 fatty acids plus inositol received 2040mg (6 340mg capsules) of omega-3 fatty acids for the duration of the study. Subjects weighing 25kg or more also received 2000mg (2 1000mg capsules) of inositol per day. Children weighing less than 25kg received 1000mg (1 1000mg capsule) of inositol per day	N-Acetylcysteine n=27 participants at risk Subjects randomized to receive NAC received NAC in either an effervescent tablet (PharmaNAC brand was chosen due to its palatability and ease of administration) or could instead opt for NAC encapsulated. For those who chose to take NAC in the effervescent tablet form, subjects age 12 and under received 1800mg daily (2 900 mg tablets) NAC and subjects age 13-17 received NAC 2700mg (3 900mg tablets) daily. For those who chose to take NAC in the capsule form, subjects age 12 and under received 1800mg (3 600mg capsules) of NAC daily and subjects age 13-17 received 2400mg (4 600mg capsules) of NAC daily.
Gastrointestinal disorders Nausea/Vomit/Diarrhea	22.2% 6/27 • Number of events 8 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	22.2% 6/27 • Number of events 9 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
General disorders Headache	11.1% 3/27 • Number of events 4 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	7.4% 2/27 • Number of events 2 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
General disorders Increased Energy	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Psychiatric disorders Tics	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Psychiatric disorders Agitated/ Irritable	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	7.4% 2/27 • Number of events 2 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Psychiatric disorders Anxious/ Worried	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Psychiatric disorders Insomnia	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
General disorders Decreased Energy	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Respiratory, thoracic and mediastinal disorders Cold/Infection/Allergy	3.7% 1/27 • Number of events 2 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Metabolism and nutrition disorders Decreased Appetite	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	3.7% 1/27 • Number of events 3 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
Skin and subcutaneous tissue disorders Dermatological	3.7% 1/27 • Number of events 1 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	0.00% 0/27 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.
General disorders Other	11.1% 3/27 • Number of events 4 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.	22.2% 6/27 • Number of events 8 • Adverse events were monitored from enrollment until end of study, on average 6 weeks. Poor response to treatment, leading to drop from the study, was measured by a CGI-bipolar score that is 2 points higher (more severe) than baseline for more than 2 consecutive weeks or a P-YMRS score that is 30% higher than baseline for more than 2 consecutive weeks only if the P-YMRS is in a clinically significant range of \>15. If a subject scores=d a 4 or higher on the C-SSRS, they were dropped from the study.

Additional Information

Janet Wozniak

Massachusetts General Hospital

Phone: 6176436617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place