Page last updated: 2024-10-18

glycine and Affective Disorders, Psychotic

glycine has been researched along with Affective Disorders, Psychotic in 3 studies

Affective Disorders, Psychotic: Disorders in which the essential feature is a severe disturbance in mood (depression, anxiety, elation, and excitement) accompanied by psychotic symptoms such as delusions, hallucinations, gross impairment in reality testing, etc.

Research Excerpts

Excerpt	Relevance	Reference
"Glycine was used in the first clinical trial, and D-cycloserine was used in the second one."	2.90	Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. ( Anderson, T; Bodkin, JA; Carvalho, CMB; Coleman, MJ; Coyle, JT; Fialkowski, A; Godfrey, LJ; Goff, DC; Grochowski, CM; Hebbring, S; Hudson, JI; Javitt, DC; Kaufman, MJ; Kirchhoff, C; Levy, DL; Lewandowski, KE; Lupski, JR; Malhotra, D; McCarthy, S; Morgan, CJ; Öngür, D; Rodriguez, SB; Rudolph, U; Rujescu, D; Sebat, J; Siegel, AJ; Suckow, RF; Visscher, T; Vuckovic, A; Waldstreicher, E; Weinshilboum, R, 2019)
"Glycine levels in RBC were also significantly higher in patients on Li+ compared to normals or Li+ free affective disorder patients."	1.26	Elevation of choline and glycine in red blood cells of psychiatric patients due to lithium treatment. ( Hendrie, HC; Shea, PA; Small, JG, 1981)

Research

Studies (3)

Timeframe	Studies, this research(%)	All Research%
pre-1990	2 (66.67)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (33.33)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Bodkin, JA	1
Coleman, MJ	1
Godfrey, LJ	1
Carvalho, CMB	1
Morgan, CJ	1
Suckow, RF	1
Anderson, T	1
Öngür, D	1
Kaufman, MJ	1
Lewandowski, KE	1
Siegel, AJ	1
Waldstreicher, E	1
Grochowski, CM	1
Javitt, DC	1
Rujescu, D	1
Hebbring, S	1
Weinshilboum, R	1
Rodriguez, SB	1
Kirchhoff, C	1
Visscher, T	1
Vuckovic, A	1
Fialkowski, A	1
McCarthy, S	1
Malhotra, D	1
Sebat, J	1
Goff, DC	1
Hudson, JI	1
Lupski, JR	1
Coyle, JT	1
Rudolph, U	1
Levy, DL	1
Prakash, R	1
Shea, PA	1
Small, JG	1
Hendrie, HC	1

Clinical Trials (2)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Pilot Study of Glycine Augmentation in Carriers of a Mutation in the Gene Encoding Glycine Decarboxylase[NCT01720316]	Phase 2	2 participants (Actual)	Interventional	2012-12-10	Completed
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine[NCT02304432]	Early Phase 1	2 participants (Actual)	Interventional	2015-09-27	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Auditory Evoked Potentials - P50 Ratio (P50 S2/P50 S1 Amplitude) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT

Auditory evoked potentials amplitude: P50 ratio (S2/S1). Participants were assessed at baseline and in week 6 of open-label glycine treatment. (NCT01720316)
Timeframe: Recordings at baseline and week 6 of glycine

Intervention	ratio (Number)
Auditory ERPs Amplitude (Deg) Baseline: Subject 2	44.51
Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2	35.67

Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT

Auditory evoked potentials amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2 amplitude; mismatch negativity (MMN) at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment. (NCT01720316)
Timeframe: Recordings at baseline and week 6 of glycine

Intervention	microvolts (Number)
	P300 amplitude at fz	P300 amplitude at cz	P300 amplitude at pz	N100 amplitude at fz	N100 amplitude at cz	P200 amplitude at fz	P200 amplitude at cz	P50 S1 amplitude	P50 S2 amplitude	MMN amplitude at fz	MMN amplitude at cz
Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2	3.74	6.6	5.57	-4.71	-3.89	6.29	7.8	2.2	0.78	-1.004	-1.322
Auditory ERPs Amplitude (Deg) Baseline: Subject 2	-0.635	6.53	5.34	-3.93	-3.62	1.662	6.59	2.76	1.23	-3.356	-4.13

Auditory Evoked Potentials in Gammas Oscillations (the Power Spectrum is Measured in Microvolts Squared) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT

Auditory evoked potentials gamma: G40 hz phase locking at fz and cz; G20 hz phase locking response at fz and cz G30 hz phase locking response at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment. (NCT01720316)
Timeframe: Recordings at baseline and week 6 of glycine

Intervention	microvolts squared (Number)
	G40 fz	G40 cz	G20 fz	G20 cz	G30 fz	G30 cz
Auditory ERPs Gamma 6 Weeks of Glycine: Subject 2	0.255	0.29	0.107	0.108	0.177	0.242
Auditory ERPs Gamma Baseline: Subject 2	0.135	0.168	0.023	0.03	0.19	0.163

Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH 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. (NCT01720316)
Timeframe: Recordings at baseline and week 6 of glycine

Intervention	msec (Number)
	P300 latency at fz	P300 latency at cz	P300 latency at pz	N100 latency at fz	N100 latency at cz	P200 latency at fz	P200 latency at cz
Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2	300.78	293	294.92	94	94	205	203
Auditory ERPs Latency (ms) Baseline: Subject 2	279.3	279.3	279.3	97.66	91.8	197.27	193.4

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

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. (NCT01720316)
Timeframe: Baseline and week 6 of glycine

Intervention	ratio (Number)
	Baseline GABA/Cr	Week 6 of glycine tx GABA/Cr
Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.16	0.22
Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine	0.27	0.24

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

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. (NCT01720316)
Timeframe: baseline and week 6 of glycine

Intervention	ratio (Number)
	Baseline brain glutamate/Cr ratio	Week 6 brain glutamate/Cr ratio
Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	0.98	0.84
Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine	2.053	1.13

Brain Glycine/CR Ratio

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 (NCT01720316)
Timeframe: 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

Intervention	ratio (Number)
	Baseline - pre-challenge drink	Baseline 60 minutes post challenge drink	Baseline 80 minutes post challenge drink	Baseline 100 minutes post challenge drink	Baseline 120 minutes post challenge drink	Week 6 of glycine - pre-glycine dose	Week 6 of glycine - 60 minutes post glycine dose	Week 6 of glycine - 80 minutes post glycine dose	Week 6 of glycine - 100 minutes post glycine dose	Week 6 of glycine - 120 minutes post glycine dose
Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.5691	0.3918	0.6428	0.6363	0.9559	0.3235	0.3807	0.5591	0.4142	0.3545
Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine	0.2558	0.6157	0.6631	0.5938	0.6953	0.6573	0.2983	0.4577	0.5751	0.3842

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

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. (NCT01720316)
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period

Intervention	units on a scale (Number)
	BPRS at baseline	BPRS at 2 weeks intervention 1	BPRS at 4 weeks intervention 1	BPRS at 6 weeks intervention 1	BPRS, end of washout1	BPRS at 2 weeks intervention 2	BPRS at 4 weeks intervention 2	BPRS at 6 weeks intervention 2	BPRS, end of washout2	BPRS at 2 weeks open label	BPRS at 4 weeks open label	BPRS at 6 weeks open label	BPRS, end of washout3
Glycine, Then Placebo	39	38	32	21	22	37	31	37	32	23	22	21	19
Placebo, Then Glycine	46	38	39	28	34	32	20	23	24	20	18	19	23

Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each 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. (NCT01720316)
Timeframe: CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period

Intervention	units on a scale (Number)
	CGI severity score at baseline	CGI severity score at 2 weeks intervention 1	CGI severity score at 4 weeks intervention 1	CGI severity score at 6 weeks intervention 1	CGI severity score, end of washout1	CGI severity score at 2 weeks intervention 2	CGI severity score at 4 weeks intervention 2	CGI severity score at 6 weeks intervention 2	CGI severity score, end of washout2	CGI severity score at 2 weeks open label	CGI severity score at 4 weeks open label	CGI severity score at 6 weeks open label	CGI severity score, end of washout3
Glycine, Then Placebo	4	4	3	2	2	4	4	4	4	3	3	2	2
Placebo, Then Glycine	4	4	4	4	4	4	4	3	3	3	3	2	2

Clinical Global Impression (CGI) Therapeutic Effect Scores 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). (NCT01720316)
Timeframe: at 2 weeks, 4 weeks, and 6 weeks within each treatment period

Intervention	score (Number)
	CGI therapeutic effect at 2 weeks intervention 1	CGI therapeutic effect at 4 weeks intervention 1	CGI therapeutic effect at 6 weeks intervention 1	CGI therapeutic effect, end of washout1	CGI therapeutic effect at 2 weeks intervention 2	CGI therapeutic effect at 4 weeks intervention 2	CGI therapeutic effect at 6 weeks intervention 2	CGI therapeutic effect, end of washout2	CGI therapeutic effect at 2 weeks open label	CGI therapeutic effect at 4 weeks open label	CGI therapeutic effect at 6 weeks open label	CGI therapeutic effect, end of washout3
Glycine, Then Placebo	13	5	5	5	13	13	13	13	5	5	1	1
Placebo, Then Glycine	5	5	5	5	13	5	5	5	1	1	1	1

Depression Symptom Scores at 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. (NCT01720316)
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period

Intervention	units on a scale (Number)
	Depression symptoms at baseline	Depression symptoms at 2 weeks intervention 1	Depression symptoms at 4 weeks intervention 1	Depression symptoms at 6 weeks intervention 1	Depression symptoms, end of washout1	Depression symptoms at 2 weeks intervention 2	Depression symptoms at 4 weeks intervention 2	Depression symptoms at 6 weeks intervention 2	Depression symptoms, end of washout2	Depression symptoms at 2 weeks open label	Depression symptoms at 4 weeks open label	Depression symptoms at 6 weeks open label	Depression symptoms, end of washout3
Glycine, Then Placebo	18	17	11	3	1	19	5	7	3	2	2	1	2
Placebo, Then Glycine	12	5	5	0	3	3	2	1	1	1	1	1	0

Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine

Plasma glycine levels; normal range is 122-467 nM/mL (NCT01720316)
Timeframe: At baseline, during glycine treatment, during placebo treatment and during open-label glycine

Intervention	nM/mL (Number)
	Baseline	Glycine double-blind	Placebo	Glycine open-label
Glycine Then Placebo	216	410	194	516
Placebo Then Glycine	271	761	347	634

Mania Symptom Scores at 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. (NCT01720316)
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period

Intervention	units on a scale (Number)
	Manic symptoms at baseline	Manic symptoms at 2 weeks intervention 1	Manic symptoms at 4 weeks intervention 1	Manic symptoms at 6 weeks intervention 1	Manic symptoms, end of washout1	Manic symptoms at 2 weeks intervention 2	Manic symptoms at 4 weeks intervention 2	Manic symptoms at 6 weeks intervention 2	Manic symptoms, end of washout2	Manic symptoms at 2 weeks open label	Manic symptoms at 4 weeks open label	Manic symptoms at 6 weeks open label	Manic symptoms, end of washout3
Glycine, Then Placebo	4	1	0	0	0	17	0	2	2	1	0	0	0
Placebo, Then Glycine	7	7	6	0	0	0	0	0	0	0	0	0	0

Neurocognitive Function 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. (NCT01720316)
Timeframe: At baseline, during glycine treatment, during placebo treatment and during open-label glycine

,,,

Intervention	units on a scale (Number)
	Participant 1	Participant 2
Baseline	45	48
Composite Score on Glycine, Double-blind	52	52
Composite Score on Glycine, Open-label	49	46
Composite Score on Placebo	52	55

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

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. (NCT01720316)
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period

Intervention	units on a scale (Number)
	Positive symptoms at baseline	Positive symptoms at 2 weeks intervention 1	Positive symptoms at 4 weeks intervention 1	Positive symptoms at 6 weeks intervention 1	Positive symptoms, end of washout1	Positive symptoms at 2 weeks intervention 2	Positive symptoms at 4 weeks intervention 2	Positive symptoms at 6 weeks intervention 2	Positive symptoms, end of washout2	Positive symptoms at 2 weeks open label	Positive symptoms at 4 weeks open label	Positive symptoms at 6 weeks open label	Positive symptoms, end of washout3
Glycine, Then Placebo	13	12	9	8	7	12	11	14	14	9	9	7	7
Placebo, Then Glycine	19	20	19	13	13	12	10	11	11	8	7	8	8

Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)

Auditory evoked potential amplitude: P50 ratio (P50 S2/S1) (NCT02304432)
Timeframe: Baseline and Week 8 of DCS treatment

Intervention	ratio (Number)
	P50 ratio: Baseline	P50 ratio: Week 8 of DCS
First Open Label DCS	44.51	30

Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)

Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz. (NCT02304432)
Timeframe: Baseline and Week 8 of DCS treatment

Intervention	microvolts (Number)
	P300 at fz: Baseline	P300 at cz: Baseline	P300 at pz: Baseline	N100 at fz: Baseline	N100 at cz: Baseline	P200 at fz: Baseline	P200 at cz: Baseline	P50 S1: Baseline	P50 S2: Baseline	MMN at fz: Baseline	MMN at cz: Baseline	P300 at fz: Week 8 of DCS	P300 at cz: Week 8 of DCS	P300 at pz: Week 8 of DCS	N100 at fz: Week 8 of DCS	N100 at cz: Week 8 of DCS	P200 at fz: Week 8 of DCS	P200 at cz: Week 8 of DCS	P50 S1: Week 8 of DCS	P50 S2: Week 8 of DCS	MMN at fz: Week 8 of DCS	MMN at cz: Week 8 of DCS
First Open Label DCS	-0.635	6.529	5.340	-3.926	-3.615	1.662	6.591	2.759	1.23	-3.356	-4.130	3.030	6.810	6.620	-3.260	-3.940	8.200	8.160	1.36	0.4	-3.330	-1.540

Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)

Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz (NCT02304432)
Timeframe: Baseline and Week 8 of DCS treatment

Intervention	microvolts squared (Number)
	G40 hz phase locking at fz: Baseline	G40 hz phase locking at cz: Baseline	G30 hz phase locking at fz: Baseline	G30 hz phase locking at cz: Baseline	G20 hz phase locking at fz: Baseline	G20 hz phase locking at cz: Baseline	G40 hz phase locking at fz: Week 8 of DCS	G40 hz phase locking at cz: Week 8 of DCS	G30 hz phase locking at fz: Week 8 of DCS	G30 hz phase locking at cz: Week 8 of DCS	G20 hz phase locking at fz: Week 8 of DCS	G20 hz phase locking at cz: Week 8 of DCS
First Open Label DCS	0.135	0.168	0.190	0.163	0.023	0.030	0.344	0.381	0.168	0.19	0.01	-0.01

Auditory Evoked Potentials in Latency (Msec)

Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz. (NCT02304432)
Timeframe: Baseline and Week 8 of DCS treatment

Intervention	msec (Number)
	P300 at fz: Baseline	P300 at cz: Baseline	P300 at pz: Baseline	N100 at fz: Baseline	N100 at cz: Baseline	P200 at fz: Baseline	P200 at cz: Baseline	P300 at fz: Week 8 of DCS	P300 at cz: Week 8 of DCS	P300 at pz: Week 8 of DCS	N100 at fz: Week 8 of DCS	N100 at cz: Week 8 of DCS	P200 at fz: Week 8 of DCS	P200 at cz: Week 8 of DCS
First Open Label DCS	279.297	279.297	279.297	97.656	91.797	197.266	193.359	294.920	294.000	294	87.9	88.000	212.890	212.000

Brain Glycine/CR Ratio

Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex. (NCT02304432)
Timeframe: Baseline and Week 8 of DCS treatment

Intervention	ratio (Median)
	Baseline	Baseline at 60 minutes	Baseline at 80 minutes	Baseline at 100 minutes	Baseline at 120 minutes	Week 8 of DCS: Baseline	Week 8 of DCS: 60 minutes	Week 8 of DCS: 80 minutes	Week 8 of DCS: 100 minutes	Week 8 of DCS: 120 minutes
Open Label DCS	0.41245	0.50375	0.65295	0.61505	0.8256	0.10977	0.248885	0.32609	0.32052	0.312155

Brief Psychiatric Rating Scale (BPRS) Scores

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. (NCT02304432)
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2

Intervention	units on a scale (Median)
	Baseline BPRS	2 weeks BPRS	4 weeks BPRS	6 weeks BPRS	8 weeks BPRS	10 weeks BPRS	12 weeks BPRS	14 weeks BPRS	16 weeks BPRS	18 weeks BPRS	20 weeks BPRS	22 weeks BPRS	24 weeks BPRS
First Open Label DCS	37	25	26	24	24.5	NA	NA	NA	NA	NA	NA	NA	NA
Second Open Label DCS	31.5	30.5	28	25.5	26	26.5	26	25.5	28.5	27	25	24.5	26.5

Brief Psychiatric Rating Scale (BPRS) Scores

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. (NCT02304432)
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)

Intervention	units on a scale (Number)
	Baseline BPRS for first intervention	2 weeks BPRS for first intervention	4 weeks BPRS for first intervention	6 weeks BPRS for first intervention	Baseline BPRS for second intervention	2 weeks BPRS for second intervention	4 weeks BPRS for second intervention	6 weeks BPRS for second intervention
DCS First, Then Placebo	26	25	25	26	39	45	45	38
Placebo First, Then DCS	29	35	33	35	36	30	27	28

Clinical Global Impression (CGI) Severity Scores

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. (NCT02304432)
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2

Intervention	units on a scale (Median)
	Baseline CGI	2 weeks CGI	4 weeks CGI	6 weeks CGI	8 weeks CGI	10 weeks CGI	12 weeks CGI	14 weeks CGI	16 weeks CGI	18 weeks CGI	20 weeks CGI	22 weeks CGI	24 weeks CGI
First Open Label DCS	4	2	2	2	2	NA	NA	NA	NA	NA	NA	NA	NA
Second Open Label DCS	2.5	2.5	2.5	2.5	2.5	3	2.5	2	2.5	2.5	2.5	2.5	2.5

Clinical Global Impression (CGI) Severity Scores

Intervention	units on a scale (Number)
	Baseline CGI for first intervention	2 weeks CGI for first intervention	4 weeks CGI for first intervention	6 weeks CGI for first intervention	Baseline CGI for second intervention	2 weeks CGI for second intervention	4 weeks CGI for second intervention	6 weeks CGI for second intervention
DCS First, Then Placebo	2	2	2	2	3	3	3	3
Placebo First, Then DCS	1	3	3	3	3	2	2	2

Depression Symptom Scores

Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 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. Higher scores indicate worse depression symptoms. (NCT02304432)
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2

Intervention	units on a scale (Median)
	Baseline HAM	2 weeks HAM	4 weeks HAM	6 weeks HAM	8 weeks HAM	10 weeks HAM	12 weeks HAM	14 weeks HAM	16 weeks HAM	18 weeks HAM	20 weeks HAM	22 weeks HAM	24 weeks HAM
First Open Label DCS	5	1.5	1	0.5	1.5	NA	NA	NA	NA	NA	NA	NA	NA
Second Open Label DCS	0.5	1	1	0	2.5	0	0	0	3.5	0	0	0	0

Depression Symptom Scores

Intervention	units on a scale (Number)
	Baseline HAM for first intervention	2 weeks HAM for first intervention	4 weeks HAM for first intervention	6 weeks HAM for first intervention	Baseline HAM for second intervention	2 weeks HAM for second intervention	4 weeks HAM for second intervention	6 weeks HAM for second intervention
DCS First, Then Placebo	0	1	0	0	2	12	9	2
Placebo First, Then DCS	4	5	2	10	0	0	0	0

Mania Symptom Scores

Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms. (NCT02304432)
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2

Intervention	units on a scale (Median)
	Baseline YMRS	2 weeks YMRS	4 weeks YMRS	6 weeks YMRS	8 weeks YMRS	10 weeks YMRS	12 weeks YMRS	14 weeks YMRS	16 weeks YMRS	18 weeks YMRS	20 weeks YMRS	22 weeks YMRS	24 weeks YMRS
First Open Label DCS	2	1	1	0	0	NA	NA	NA	NA	NA	NA	NA	NA
Second Open Label DCS	0	0	0	0	0	0	0	0	0	0	0	0	1

Mania Symptom Scores

Intervention	units on a scale (Number)
	Baseline YMRS for first intervention	2 weeks YMRS for first intervention	4 weeks YMRS for first intervention	6 weeks YMRS for first intervention	Baseline YMRS for second intervention	2 weeks YMRS for second intervention	4 weeks YMRS for second intervention	6 weeks YMRS for second intervention
DCS First, Then Placebo	0	0	0	0	0	0	0	0
Placebo First, Then DCS	1	0	0	0	4	1	1	1

Neurocognitive Function

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. Higher scores signify better functioning. (NCT02304432)
Timeframe: Baseline and Week 8 of open-label DCS treatment

Intervention	T scores (Median)
	Baseline Processing Speed	Baseline Attention/Vigilance	Baseline Working Memory	Baseline Verbal Learning	Baseline Visual Learning	Baseline Reasoning/Problem Solving	Baseline Social Cognition	Baseline Overall Composite Score	Week 8 of open-label DCS Processing Speed	Week 8 of open-label DCS Attention/Vigilance	Week 8 of open-label DCS Working Memory	Week 8 of open-label DCS Verbal Learning	Week 8 of open-label DCS Visual Learning	Week 8 of open-label DCS Reasoning/Problem Solving	Week 8 of open-label DCS Social Cognition	Week 8 of open-label DCS Overall Composite Score
Open Label DCS	48.5	44.5	38.5	54	50.5	52.5	48	46.5	52.5	47.5	50.5	43.5	54.5	66.5	44.5	51.5

Positive and Negative Symptom Scores

Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms. (NCT02304432)
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2

Intervention	units on a scale (Median)
	Baseline positive	Baseline negative	2 weeks positive	2 weeks negative	4 weeks positive	4 weeks negative	6 weeks positive	6 weeks negative	8 weeks positive	8 weeks negative	10 weeks positive	10 weeks negative	12 weeks positive	12 weeks negative	14 weeks positive	14 weeks negative	16 weeks positive	16 weeks negative	18 weeks positive	18 weeks negative	20 weeks positive	20 weeks negative	22 weeks positive	22 weeks negative	24 weeks positive	24 weeks negative
First Open Label DCS	14.5	14.5	10	12	10.5	12	9	12	9	12	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA
Second Open Label DCS	11	14	11	14	10.5	13.5	9	13	9.5	12	10.5	13	11	12	10	12	10.5	12	10.5	12	10.5	12	9.5	12	10	12

Positive and Negative Symptom Scores

Intervention	units on a scale (Number)
	Baseline positive for first intervention	Baseline negative symptoms for first intervention	2 weeks positive for first intervention	2 weeks negative for first intervention	4 weeks positive for first intervention	4 weeks negative for first intervention	6 weeks positive for first intervention	6 weeks negative for first intervention	Baseline positive for second intervention	Baseline negative for second intervention	2 weeks positive for second intervention	2 weeks negative for second intervention	4 weeks positive for second intervention	4 weeks negative for second intervention	6 weeks positive for second intervention	6 weeks negative for second intervention
DCS First, Then Placebo	10	15	10	15	10	15	10	15	15	18	15	18	15	18	14	18
Placebo First, Then DCS	11	9	12	15	11	13	13	13	13	13	10	11	9	11	9	11

Trials

1 trial available for glycine and Affective Disorders, Psychotic

Article	Year
Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. Biological psychiatry, 2019, 10-01, Volume: 86, Issue:7 Topics: Adult; Affective Disorders, Psychotic; DNA Copy Number Variations; Double-Blind Method; Drug Synergi	2019
Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. Biological psychiatry, 2019, 10-01, Volume: 86, Issue:7 Topics: Adult; Affective Disorders, Psychotic; DNA Copy Number Variations; Double-Blind Method; Drug Synergi	2019
Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. Biological psychiatry, 2019, 10-01, Volume: 86, Issue:7 Topics: Adult; Affective Disorders, Psychotic; DNA Copy Number Variations; Double-Blind Method; Drug Synergi	2019
Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. Biological psychiatry, 2019, 10-01, Volume: 86, Issue:7 Topics: Adult; Affective Disorders, Psychotic; DNA Copy Number Variations; Double-Blind Method; Drug Synergi	2019

Other Studies

2 other studies available for glycine and Affective Disorders, Psychotic

Article	Year
Lithium and glycine levels. The American journal of psychiatry, 1982, Volume: 139, Issue:1 Topics: Affective Disorders, Psychotic; Animals; Erythrocytes; Glycine; Humans; Lithium; Rats	1982
Elevation of choline and glycine in red blood cells of psychiatric patients due to lithium treatment. Biological psychiatry, 1981, Volume: 16, Issue:9 Topics: Adult; Affective Disorders, Psychotic; Choline; Erythrocytes; Female; Glycine; Humans; Lithium; Male	1981