Trial Outcomes & Findings for Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism (NCT NCT00338598)

Results Overview

Percentage of drinking days and heavy drinking days using timeline follow back

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-01-17

Participant Flow

Participants were recruited from the VA hospital in West Haven, CT and the Community Mental Health Center in New Haven, CT through word of mouth, advertisement and clinician referrals.

Twenty men, who met DSM IV criteria for schizophrenia or schizoaffective disorder, who also met DSM IV diagnosis of alcohol dependence with at least one recent episode of heavy drinking (defined as more than 5 drinks/drinking episode) over the past 14 days participated in the study. The participants were in stable treatment for at least 2 weeks.

Participant milestones

Participant milestones
Measure	Glycine Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo placebo will be administered. placebo
Overall Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glycine n=10 Participants Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 Participants placebo will be administered. placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 4.8 • n=5 Participants	48.6 years STANDARD_DEVIATION 5.0 • n=7 Participants	48.9 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Drinks per day	8.9 drinks per day STANDARD_DEVIATION 8.5 • n=5 Participants	5.9 drinks per day STANDARD_DEVIATION 5.0 • n=7 Participants	7.5 drinks per day STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Percentage of drinking days and heavy drinking days using timeline follow back

Outcome measures

Outcome measures
Measure	Glycine n=10 Participants Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 Participants placebo will be administered. placebo
Self Reported Weekly Alcohol Consumption % number of drinking days	23.4 percentage of days Standard Error 28.8	19.6 percentage of days Standard Error 29.0
Self Reported Weekly Alcohol Consumption % number of heavy drinking days	15.7 percentage of days Standard Error 20.8	10.0 percentage of days Standard Error 12.6

PRIMARY outcome

Timeframe: 12 weeks

The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.

Outcome measures

Outcome measures
Measure	Glycine n=10 Participants Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 Participants placebo will be administered. placebo
Self Reported Weekly Alcohol Craving Baseline	16.1 units on a scale Standard Error 3.1	17.5 units on a scale Standard Error 3.2
Self Reported Weekly Alcohol Craving Week 12	10.2 units on a scale Standard Error 3.1	12.1 units on a scale Standard Error 3.3

PRIMARY outcome

Timeframe: 12 weeks

The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms for each scale.

Outcome measures

Outcome measures
Measure	Glycine n=10 Participants Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 Participants placebo will be administered. placebo
Weekly Ratings of Negative/Positive Psychotic Symptoms Baseline Positive	16.3 units on a scale Standard Error 1.3	15.3 units on a scale Standard Error 1.3
Weekly Ratings of Negative/Positive Psychotic Symptoms Week 12 Positive	12.0 units on a scale Standard Error 1.3	13.5 units on a scale Standard Error 1.4
Weekly Ratings of Negative/Positive Psychotic Symptoms Baseline Negative	16.7 units on a scale Standard Error 1.5	12.5 units on a scale Standard Error 1.6
Weekly Ratings of Negative/Positive Psychotic Symptoms Week 12 Negative	14.9 units on a scale Standard Error 1.5	13.0 units on a scale Standard Error 1.6
Weekly Ratings of Negative/Positive Psychotic Symptoms Baseline General	32.4 units on a scale Standard Error 2.5	29.4 units on a scale Standard Error 2.6
Weekly Ratings of Negative/Positive Psychotic Symptoms Week 12 General	31.9 units on a scale Standard Error 2.5	29.8 units on a scale Standard Error 2.7

PRIMARY outcome

Timeframe: 12 weeks

Hopkins Verbal Learning Test Assesses short term verbal learning and memory. Subscales include immediate recall (0-36), delayed recall (0-12) , and recognition (0-12). A higher score indicates better memory performance.

Outcome measures

Outcome measures
Measure	Glycine n=10 Participants Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 Participants placebo will be administered. placebo
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) Baseline Immediate Recall	21.8 units on a scale Standard Error 1.7	19.7 units on a scale Standard Error 1.7
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) 12 Weeks Immediate Recall	20.9 units on a scale Standard Error 1.8	19.5 units on a scale Standard Error 1.8
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) Baseline Delayed Recall	6.1 units on a scale Standard Error 0.9	6.4 units on a scale Standard Error 0.9
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) 12 Weeks Delayed Recall	6.6 units on a scale Standard Error 0.9	6.5 units on a scale Standard Error 0.9
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) Baseline Recognition	10.2 units on a scale Standard Error 1.0	12.5 units on a scale Standard Error 1.0
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) 12 Weeks Recognition	9.8 units on a scale Standard Error 1.0	12.2 units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected

Outcome measures

Outcome data not reported

Adverse Events

Glycine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Glycine n=10 participants at risk Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses	Placebo n=10 participants at risk placebo will be administered. placebo
General disorders ER for intoxication	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks
Respiratory, thoracic and mediastinal disorders Chest Pain	0.00% 0/10 • 12 weeks	10.0% 1/10 • 12 weeks
General disorders ER Visit	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Gastrointestinal disorders Diarrhea	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Gastrointestinal disorders Vomiting	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
General disorders Relapse	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks
Psychiatric disorders auditory hallucinations	10.0% 1/10 • 12 weeks	0.00% 0/10 • 12 weeks

Additional Information

Elizabeth Ralevski Assistant Professor of Psychiatry

Yale University

Phone: +1 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place