NCT01720316 is a Phase 2 clinical trial of Glycine in Schizo-affective Disorder, sponsored by Mclean Hospital.

Who is sponsoring NCT01720316?

NCT01720316 is sponsored by Mclean Hospital.

What drugs are being tested in NCT01720316?

Interventions in NCT01720316: Glycine, placebo.

What condition does NCT01720316 study?

NCT01720316 studies Schizo-affective Disorder, Bipolar Disorder.

Is NCT01720316 still recruiting?

NCT01720316 is currently completed. Last updated 19 September 2017.

Are results published for NCT01720316?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-09-19 · How we verify

NCT01720316

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders

Completed Phase 2 Results posted Last updated 19 September 2017

What this trial tests

Phase 2 trial testing Glycine in Schizo-affective Disorder in 2 participants. Completed in 31 May 2017.

Timeline

10 December 2012

Primary endpoint
31 May 2017

31 May 2017

Quick facts

Lead sponsor	Mclean Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	10 December 2012
Primary completion	31 May 2017
Estimated completion	31 May 2017
Sites	1 location across United States

Drugs / interventions tested

Glycine (GLYCINE) — full drug profile →
placebo

Conditions studied

Schizo-affective Disorder — all drugs for Schizo-affective Disorder →
Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Mclean Hospital

Who can join

Adults 18 to 65, any sex, with Schizo-affective Disorder or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Positive symptoms at baseline

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	19

Positive symptoms at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	12
Placebo, Then Glycine	20

Positive symptoms at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	9
Placebo, Then Glycine	19

Positive symptoms at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	8
Placebo, Then Glycine	13

Positive symptoms, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	7
Placebo, Then Glycine	13

Positive symptoms at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	12
Placebo, Then Glycine	12

Positive symptoms at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	11
Placebo, Then Glycine	10

Positive symptoms at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	14
Placebo, Then Glycine	11

Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine Primary · 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.

Participant 1

Group	Value	95% CI
Baseline	45
Composite Score on Glycine, Double-blind	52
Composite Score on Placebo	52
Composite Score on Glycine, Open-label	49

Participant 2

Group	Value	95% CI
Baseline	48
Composite Score on Glycine, Double-blind	52
Composite Score on Placebo	55
Composite Score on Glycine, Open-label	46

Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine Primary · At baseline, during glycine treatment, during placebo treatment and during open-label glycine

Plasma glycine levels; normal range is 122-467 nM/mL

Baseline

Group	Value	95% CI
Glycine Then Placebo	216
Placebo Then Glycine	271

Glycine double-blind

Group	Value	95% CI
Glycine Then Placebo	410
Placebo Then Glycine	761

Placebo

Group	Value	95% CI
Glycine Then Placebo	194
Placebo Then Glycine	347

Glycine open-label

Group	Value	95% CI
Glycine Then Placebo	516
Placebo Then Glycine	634

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 Primary · 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.

BPRS at baseline

Group	Value	95% CI
Glycine, Then Placebo	39
Placebo, Then Glycine	46

BPRS at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	38
Placebo, Then Glycine	38

BPRS at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	32
Placebo, Then Glycine	39

BPRS at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	21
Placebo, Then Glycine	28

BPRS, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	22
Placebo, Then Glycine	34

BPRS at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	37
Placebo, Then Glycine	32

BPRS at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	31
Placebo, Then Glycine	20

BPRS at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	37
Placebo, Then Glycine	23

Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period Primary · 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.

CGI severity score at baseline

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	4

CGI severity score at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	4

CGI severity score at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	3
Placebo, Then Glycine	4

CGI severity score at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	2
Placebo, Then Glycine	4

CGI severity score, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	2
Placebo, Then Glycine	4

CGI severity score at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	4

CGI severity score at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	4

CGI severity score at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	3

Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period Primary · 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).

CGI therapeutic effect at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	5

CGI therapeutic effect at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	5
Placebo, Then Glycine	5

CGI therapeutic effect at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	5
Placebo, Then Glycine	5

CGI therapeutic effect, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	5
Placebo, Then Glycine	5

CGI therapeutic effect at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	13

CGI therapeutic effect at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	5

CGI therapeutic effect at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	5

CGI therapeutic effect, end of washout2

Group	Value	95% CI
Glycine, Then Placebo	13
Placebo, Then Glycine	5

Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period Primary · 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.

Manic symptoms at baseline

Group	Value	95% CI
Glycine, Then Placebo	4
Placebo, Then Glycine	7

Manic symptoms at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	1
Placebo, Then Glycine	7

Manic symptoms at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	0
Placebo, Then Glycine	6

Manic symptoms at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	0
Placebo, Then Glycine	0

Manic symptoms, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	0
Placebo, Then Glycine	0

Manic symptoms at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	17
Placebo, Then Glycine	0

Manic symptoms at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	0
Placebo, Then Glycine	0

Manic symptoms at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	2
Placebo, Then Glycine	0

Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period Primary · 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 depres

Depression symptoms at baseline

Group	Value	95% CI
Glycine, Then Placebo	18
Placebo, Then Glycine	12

Depression symptoms at 2 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	17
Placebo, Then Glycine	5

Depression symptoms at 4 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	11
Placebo, Then Glycine	5

Depression symptoms at 6 weeks intervention 1

Group	Value	95% CI
Glycine, Then Placebo	3
Placebo, Then Glycine	0

Depression symptoms, end of washout1

Group	Value	95% CI
Glycine, Then Placebo	1
Placebo, Then Glycine	3

Depression symptoms at 2 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	19
Placebo, Then Glycine	3

Depression symptoms at 4 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	5
Placebo, Then Glycine	2

Depression symptoms at 6 weeks intervention 2

Group	Value	95% CI
Glycine, Then Placebo	7
Placebo, Then Glycine	1

Brain Glycine/CR Ratio Secondary · 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

Baseline - pre-challenge drink

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.2558
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.5691

Baseline 60 minutes post challenge drink

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6157
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.3918

Baseline 80 minutes post challenge drink

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6631
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6428

Baseline 100 minutes post challenge drink

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.5938
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6363

Baseline 120 minutes post challenge drink

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6953
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.9559

Week 6 of glycine - pre-glycine dose

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.6573
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.3235

Week 6 of glycine - 60 minutes post glycine dose

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.2983
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.3807

Week 6 of glycine - 80 minutes post glycine dose

Group	Value	95% CI
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.4577
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.5591

Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT Secondary · 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.

Baseline brain glutamate/Cr ratio

Group	Value	95% CI
Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	0.98
Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	2.053

Week 6 brain glutamate/Cr ratio

Group	Value	95% CI
Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	0.84
Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	1.13

Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT Secondary · Baseline and week 6 of glycine

Magnetic resonance spectroscopy GABA/Cr. Participants were assessed 1) pre-glycine treatment (baseline) and 2) in week 6 of open-label glycine treatment measured in posterior occipital cortex.

Baseline GABA/Cr

Group	Value	95% CI
Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.16
Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.27

Week 6 of glycine tx GABA/Cr

Group	Value	95% CI
Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.22
Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.24

Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE Secondary · Recordings at baseline and week 6 of glycine

Auditory evoked potentials latency: P300 at fz, cz, and pz); N100 at fz and cz); P200 at fz and cz. Participants were assessed at baseline and in week of open-label glycine treatment.

P300 latency at fz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	279.3
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	300.78

P300 latency at cz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	279.3
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	293

P300 latency at pz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	279.3
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	294.92

N100 latency at fz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	97.66
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	94

N100 latency at cz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	91.8
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	94

P200 latency at fz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	197.27
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	205

P200 latency at cz

Group	Value	95% CI
Auditory ERPs Latency (ms) Baseline: Subject 2	193.4
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	203

Adverse events — posted to ClinicalTrials.gov

Time frame: 26 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Glycine

Serious: 0/2 (0%)

Deaths: 0/2

Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (3 terms — click to expand)

Reaction	System	Glycine	Placebo
nausea	Gastrointestinal disorders	—	—
vomiting	Gastrointestinal disorders	—	—
diarrhea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT01720316 adverse events section.

Sponsor's own description

The purpose of this study is to assess the efficacy of oral glycine as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the gene glycine decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week period of no treatment will occur between treatment arms. A 6-week period of open-label glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow the double-blind placebo-controlled clinical trial. Prior to the double-blind placebo-controlled clinical trial and at the end of the open-label glycine trial, the following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T), steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital Pharmacy. Because the results of the double-blind placebo-controlled and open-label glycine treatment arms showed substantial clinical benefit to the participants, the study has been extended to include six months of chronic open-label glycine in order to determine 1) whether the clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this extension will be provided by Letco Medical. The investigators hypothesize that mutation carriers will have reduced endogenous brain glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine administration will increase brain glycine in the two carriers, but to a lesser extent than in non-carrier family members and controls. The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs modulated by NMDA in mutation carriers compared with non-carrier family members and controls. The investigators hypothesize that glycine, but not placebo, will improve positive, negative and affective symptoms as well as neurocognitive function. The investigators also hypothesize that open-label glycine will improve clinical and cognitive functioning, will partially normalize decreased baseline glycine and GABA and increased glutamate and glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked potentials.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01720316 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mclean Hospital
Last refreshed: 19 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01720316.

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