Trial · NCT01720316

Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders

NCT01720316, Phase 2, Completed, Mclean Hospital; results first posted 2017-04-18

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders. Trials, record NCT01720316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720316

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders
NCT number: NCT01720316
Status: Completed
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Mclean Hospital
Conditions: Schizo-affective Disorder, Bipolar Disorder
Interventions: Glycine, placebo
First posted: 2012-11-02
Last updated: 2017-09-19
Results first posted: 2017-04-18

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period	Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms are measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.
Primary	Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine	At baseline, during glycine treatment, during placebo treatment and during open-label glycine	Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution; standard deviation of 10. Only overall composite score is entered.
Primary	Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine	At baseline, during glycine treatment, during placebo treatment and during open-label glycine	Plasma glycine levels; normal range is 122-467 nM/mL
Primary	Brief Psychiatric Rating Scale (BPRS) Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Positive and Negative Symptom Scores at Baseline and at 2, 4, and 6 Weeks During Intervention 1, Intervention 2, and During Open-label Glycine	baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period	Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.
Primary	Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period	Clinical Global Impression (CGI) severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.
Primary	Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	at 2 weeks, 4 weeks, and 6 weeks within each treatment period	Clinical Global Impression (CGI) therapeutic effect scores measure degree of improvement as marked (1), moderate (5), minimal (9) or unchanged/worse (13).
Primary	Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period	Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of ratings for 7 symptoms of mania is measured on a scale from 0-4 and the sum of 4 symptoms of mania is measured on a scale from 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.
Primary	Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period	Hamilton Depression Scale measures severity of depression symptoms. The sum of ratings for 9 depression symptoms are measured on a scale from 0-2 with 0 meaning no symptoms and 2 meaning some level of severity of that specific symptom. The rating for 1 depression symptom is measured on a scale from 0-3 with 0 meaning no symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms are measured on a scale from 0-4 with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65.
Secondary	Brain Glycine/CR Ratio	baseline (pre-challenge, 60, 80, 100, 120 minutes post-challenge), and week 6 of glycine (pre-dose and 60, 80, 100, 120 minutes post-dose	magnetic resonance spectroscopy: glycine/creatine ratio. Participants were assessed at 1) BASELINE PRE-GLYCINE TREATMENT: pre-glycine challenge drink, 60 minutes post challenge drink, 80 minutes post challenge drink, 100 minutes post challenge drink, and 120 minutes post challenge drink (0.4 g/kg up to max of 30 g); and 2) IN WEEK 6 OF OPEN-LABEL GLYCINE TREATMENT: pre-glycine dose, and 60 minutes, 80 minutes, 100 minutes and 120 minutes post daily dose of glycine. Measured in posterior occipital cortex
Secondary	Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT	baseline and week 6 of glycine	magnetic resonance spectroscopy - glutamate metabolite level. Participants were assessed 1) pre-glycine treatment and in week 6 of open-label glycine treatment. Measured in posterior occipital cortex.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period		units on a scale	NUMBER
PRIMARY	Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine	At baseline, during glycine treatment, during placebo treatment and during open-label glycine	Data provided for each participant separately.	units on a scale	NUMBER
PRIMARY	Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine	At baseline, during glycine treatment, during placebo treatment and during open-label glycine		nM/mL	NUMBER
PRIMARY	Brief Psychiatric Rating Scale (BPRS) Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Positive and Negative Symptom Scores at Baseline and at 2, 4, and 6 Weeks During Intervention 1, Intervention 2, and During Open-label Glycine	baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period		units on a scale	NUMBER
PRIMARY	Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period		units on a scale	NUMBER
PRIMARY	Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	at 2 weeks, 4 weeks, and 6 weeks within each treatment period		score	NUMBER
PRIMARY	Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period		units on a scale	NUMBER
PRIMARY	Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period	baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period		units on a scale	NUMBER
SECONDARY	Brain Glycine/CR Ratio	baseline (pre-challenge, 60, 80, 100, 120 minutes post-challenge), and week 6 of glycine (pre-dose and 60, 80, 100, 120 minutes post-dose		ratio	NUMBER
SECONDARY	Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT	baseline and week 6 of glycine		ratio	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group248

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Glycine, Then Placebo	Positive symptoms at baseline	13	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Placebo, Then Glycine	Positive symptoms at baseline	19	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Glycine, Then Placebo	Positive symptoms at 2 weeks intervention 1	12	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Placebo, Then Glycine	Positive symptoms at 2 weeks intervention 1	20	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Glycine, Then Placebo	Positive symptoms at 4 weeks intervention 1	9	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Placebo, Then Glycine	Positive symptoms at 4 weeks intervention 1	19	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Glycine, Then Placebo	Positive symptoms at 6 weeks intervention 1	8	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Placebo, Then Glycine	Positive symptoms at 6 weeks intervention 1	13	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Glycine, Then Placebo	Positive symptoms, end of washout1	7	units on a scale
Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine	Placebo, Then Glycine	Positive symptoms, end of washout1	13	units on a scale

1 to 10 of 248Source ClinicalTrials.gov

See all 248 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-Blind Glycine Placebo Crossover	STARTED	Glycine, Then Placebo	1
Double-Blind Glycine Placebo Crossover	STARTED	Placebo, Then Glycine	1
Double-Blind Glycine Placebo Crossover	COMPLETED	Glycine, Then Placebo	1
Double-Blind Glycine Placebo Crossover	COMPLETED	Placebo, Then Glycine	1
Double-Blind Glycine Placebo Crossover	NOT COMPLETED	Glycine, Then Placebo	0
Double-Blind Glycine Placebo Crossover	NOT COMPLETED	Placebo, Then Glycine	0
Open-label Glycine	STARTED	Glycine, Then Placebo	1
Open-label Glycine	STARTED	Placebo, Then Glycine	1
Open-label Glycine	COMPLETED	Glycine, Then Placebo	1
Open-label Glycine	COMPLETED	Placebo, Then Glycine	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	nausea	Gastrointestinal disorders	Glycine	2	2
other	nausea	Gastrointestinal disorders	Placebo	0	2
other	vomiting	Gastrointestinal disorders	Glycine	2	2
other	vomiting	Gastrointestinal disorders	Placebo	0	2
other	diarrhea	Gastrointestinal disorders	Glycine	2	2
other	diarrhea	Gastrointestinal disorders	Placebo	0	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glycine	0	2
Total, all-cause mortality	Placebo	0	2
Total, other adverse events	Glycine	2	2
Total, other adverse events	Placebo	0	2
Total, serious adverse events	Glycine	0	2
Total, serious adverse events	Placebo	0	2

Source ClinicalTrials.gov

Papers34

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
7492260	BACKGROUND	PubMed
8932891	BACKGROUND	PubMed
8942463	BACKGROUND	PubMed
9836012	BACKGROUND	PubMed
9892253	BACKGROUND	PubMed
10071726	BACKGROUND	PubMed
10432468	BACKGROUND	PubMed
10553752	BACKGROUND	PubMed
10784481	BACKGROUND	PubMed
11431235	BACKGROUND	PubMed

1 to 10 of 34

See all 34 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21MH097470	Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders	LEVY, DEBORAH L	MCLEAN HOSPITAL	NATIONAL INSTITUTE OF MENTAL HEALTH	2012 to 2014

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Glycine vs Placebo: deaths from any cause	Trial comparisons
Glycine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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