Trial Outcomes & Findings for Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders (NCT NCT01720316)
NCT ID: NCT01720316
Last Updated: 2017-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
Glycine, Then Placebo
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
|
Placebo, Then Glycine
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
|
|---|---|---|
|
Double-Blind Glycine Placebo Crossover
STARTED
|
1
|
1
|
|
Double-Blind Glycine Placebo Crossover
COMPLETED
|
1
|
1
|
|
Double-Blind Glycine Placebo Crossover
NOT COMPLETED
|
0
|
0
|
|
Open-label Glycine
STARTED
|
1
|
1
|
|
Open-label Glycine
COMPLETED
|
1
|
1
|
|
Open-label Glycine
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders
Baseline characteristics by cohort
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
59 years
n=5 Participants
|
32 years
n=7 Participants
|
45.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment periodPositive 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
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 symptoms at baseline
|
13 units on a scale
|
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
Positive symptoms at 2 weeks intervention 1
|
12 units on a scale
|
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
Positive symptoms at 4 weeks intervention 1
|
9 units on a scale
|
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
Positive symptoms at 6 weeks intervention 1
|
8 units on a scale
|
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
Positive symptoms, end of washout1
|
7 units on a scale
|
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
Positive symptoms at 2 weeks intervention 2
|
12 units on a scale
|
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
Positive symptoms at 4 weeks intervention 2
|
11 units on a scale
|
10 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
Positive symptoms at 6 weeks intervention 2
|
14 units on a scale
|
11 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
Positive symptoms, end of washout2
|
14 units on a scale
|
11 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
Positive symptoms at 2 weeks open label
|
9 units on a scale
|
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
Positive symptoms at 4 weeks open label
|
9 units on a scale
|
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
Positive symptoms at 6 weeks open label
|
7 units on a scale
|
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
Positive symptoms, end of washout3
|
7 units on a scale
|
8 units on a scale
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline, during glycine treatment, during placebo treatment and during open-label glycinePopulation: Data provided for each participant separately.
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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=2 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=2 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
n=2 Participants
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
n=2 Participants
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Participant 1
|
45 units on a scale
|
52 units on a scale
|
52 units on a scale
|
49 units on a scale
|
|
Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Participant 2
|
48 units on a scale
|
52 units on a scale
|
55 units on a scale
|
46 units on a scale
|
PRIMARY outcome
Timeframe: At baseline, during glycine treatment, during placebo treatment and during open-label glycinePlasma glycine levels; normal range is 122-467 nM/mL
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Glycine open-label
|
516 nM/mL
|
634 nM/mL
|
—
|
—
|
|
Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Baseline
|
216 nM/mL
|
271 nM/mL
|
—
|
—
|
|
Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Glycine double-blind
|
410 nM/mL
|
761 nM/mL
|
—
|
—
|
|
Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine
Placebo
|
194 nM/mL
|
347 nM/mL
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment periodTotal 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
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
BPRS at baseline
|
39 units on a scale
|
46 units on a scale
|
—
|
—
|
|
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
BPRS at 2 weeks intervention 1
|
38 units on a scale
|
38 units on a scale
|
—
|
—
|
|
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
BPRS at 4 weeks intervention 1
|
32 units on a scale
|
39 units on a scale
|
—
|
—
|
|
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
BPRS at 6 weeks intervention 1
|
21 units on a scale
|
28 units on a scale
|
—
|
—
|
|
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
BPRS, end of washout1
|
22 units on a scale
|
34 units on a scale
|
—
|
—
|
|
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
BPRS at 2 weeks intervention 2
|
37 units on a scale
|
32 units on a scale
|
—
|
—
|
|
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
BPRS at 4 weeks intervention 2
|
31 units on a scale
|
20 units on a scale
|
—
|
—
|
|
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
BPRS at 6 weeks intervention 2
|
37 units on a scale
|
23 units on a scale
|
—
|
—
|
|
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
BPRS, end of washout2
|
32 units on a scale
|
24 units on a scale
|
—
|
—
|
|
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
BPRS at 2 weeks open label
|
23 units on a scale
|
20 units on a scale
|
—
|
—
|
|
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
BPRS at 4 weeks open label
|
22 units on a scale
|
18 units on a scale
|
—
|
—
|
|
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
BPRS at 6 weeks open label
|
21 units on a scale
|
19 units on a scale
|
—
|
—
|
|
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
BPRS, end of washout3
|
19 units on a scale
|
23 units on a scale
|
—
|
—
|
PRIMARY outcome
Timeframe: CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment periodClinical 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at baseline
|
4 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 2 weeks intervention 1
|
4 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 4 weeks intervention 1
|
3 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 6 weeks intervention 1
|
2 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score, end of washout1
|
2 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 2 weeks intervention 2
|
4 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 4 weeks intervention 2
|
4 units on a scale
|
4 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 6 weeks intervention 2
|
4 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score, end of washout2
|
4 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 2 weeks open label
|
3 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 4 weeks open label
|
3 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score at 6 weeks open label
|
2 units on a scale
|
2 units on a scale
|
—
|
—
|
|
Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI severity score, end of washout3
|
2 units on a scale
|
2 units on a scale
|
—
|
—
|
PRIMARY outcome
Timeframe: at 2 weeks, 4 weeks, and 6 weeks within each treatment periodClinical Global Impression (CGI) therapeutic effect scores measure degree of improvement as marked (1), moderate (5), minimal (9) or unchanged/worse (13).
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 2 weeks intervention 1
|
13 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 4 weeks intervention 1
|
5 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 6 weeks intervention 1
|
5 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect, end of washout1
|
5 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 2 weeks intervention 2
|
13 score
|
13 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 4 weeks intervention 2
|
13 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 6 weeks intervention 2
|
13 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect, end of washout2
|
13 score
|
5 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 2 weeks open label
|
5 score
|
1 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 4 weeks open label
|
5 score
|
1 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect at 6 weeks open label
|
1 score
|
1 score
|
—
|
—
|
|
Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
CGI therapeutic effect, end of washout3
|
1 score
|
1 score
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment periodYoung 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at baseline
|
4 units on a scale
|
7 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 2 weeks intervention 1
|
1 units on a scale
|
7 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 4 weeks intervention 1
|
0 units on a scale
|
6 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 6 weeks intervention 1
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms, end of washout1
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 2 weeks intervention 2
|
17 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 4 weeks intervention 2
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 6 weeks intervention 2
|
2 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms, end of washout2
|
2 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 2 weeks open label
|
1 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 4 weeks open label
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms at 6 weeks open label
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Manic symptoms, end of washout3
|
0 units on a scale
|
0 units on a scale
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment periodHamilton 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 6 weeks intervention 2
|
7 units on a scale
|
1 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms, end of washout2
|
3 units on a scale
|
1 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at baseline
|
18 units on a scale
|
12 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 2 weeks intervention 1
|
17 units on a scale
|
5 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 4 weeks intervention 1
|
11 units on a scale
|
5 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 6 weeks intervention 1
|
3 units on a scale
|
0 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms, end of washout1
|
1 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 2 weeks intervention 2
|
19 units on a scale
|
3 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 4 weeks intervention 2
|
5 units on a scale
|
2 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 2 weeks open label
|
2 units on a scale
|
1 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 4 weeks open label
|
2 units on a scale
|
1 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms at 6 weeks open label
|
1 units on a scale
|
1 units on a scale
|
—
|
—
|
|
Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period
Depression symptoms, end of washout3
|
2 units on a scale
|
0 units on a scale
|
—
|
—
|
SECONDARY outcome
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-dosemagnetic 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
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Brain Glycine/CR Ratio
Baseline - pre-challenge drink
|
0.2558 ratio
|
0.5691 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Baseline 60 minutes post challenge drink
|
0.6157 ratio
|
0.3918 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Baseline 80 minutes post challenge drink
|
0.6631 ratio
|
0.6428 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Baseline 100 minutes post challenge drink
|
0.5938 ratio
|
0.6363 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Baseline 120 minutes post challenge drink
|
0.6953 ratio
|
0.9559 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Week 6 of glycine - pre-glycine dose
|
0.6573 ratio
|
0.3235 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Week 6 of glycine - 60 minutes post glycine dose
|
0.2983 ratio
|
0.3807 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Week 6 of glycine - 80 minutes post glycine dose
|
0.4577 ratio
|
0.5591 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Week 6 of glycine - 100 minutes post glycine dose
|
0.5751 ratio
|
0.4142 ratio
|
—
|
—
|
|
Brain Glycine/CR Ratio
Week 6 of glycine - 120 minutes post glycine dose
|
0.3842 ratio
|
0.3545 ratio
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and week 6 of glycinemagnetic 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
Baseline brain glutamate/Cr ratio
|
0.98 ratio
|
2.053 ratio
|
—
|
—
|
|
Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
Week 6 brain glutamate/Cr ratio
|
0.84 ratio
|
1.13 ratio
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 6 of glycineMagnetic 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.
Outcome measures
| Measure |
Glycine, Then Placebo
n=1 Participants
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
n=1 Participants
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
Baseline GABA/Cr
|
0.16 ratio
|
0.27 ratio
|
—
|
—
|
|
Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
Week 6 of glycine tx GABA/Cr
|
0.22 ratio
|
0.24 ratio
|
—
|
—
|
SECONDARY outcome
Timeframe: Recordings at baseline and week 6 of glycinePopulation: Only one subject received these procedures because normal hearing is required.
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.
Outcome measures
| Measure |
Glycine, Then Placebo
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
n=1 Participants
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
n=1 Participants
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
P200 latency at fz
|
—
|
—
|
197.27 msec
|
205 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
P200 latency at cz
|
—
|
—
|
193.4 msec
|
203 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
P300 latency at fz
|
—
|
—
|
279.3 msec
|
300.78 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
P300 latency at cz
|
—
|
—
|
279.3 msec
|
293 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
P300 latency at pz
|
—
|
—
|
279.3 msec
|
294.92 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
N100 latency at fz
|
—
|
—
|
97.66 msec
|
94 msec
|
|
Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE
N100 latency at cz
|
—
|
—
|
91.8 msec
|
94 msec
|
SECONDARY outcome
Timeframe: 6 weeks per treatment armPopulation: Data not collected.
functional magnetic resonance imaging
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Recordings at baseline and week 6 of glycinePopulation: Only one subject received these procedures because normal hearing is required.
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.
Outcome measures
| Measure |
Glycine, Then Placebo
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
n=1 Participants
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
n=1 Participants
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P300 amplitude at fz
|
—
|
—
|
-0.635 microvolts
|
3.74 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P300 amplitude at cz
|
—
|
—
|
6.53 microvolts
|
6.6 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P300 amplitude at pz
|
—
|
—
|
5.34 microvolts
|
5.57 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
N100 amplitude at fz
|
—
|
—
|
-3.93 microvolts
|
-4.71 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
N100 amplitude at cz
|
—
|
—
|
-3.62 microvolts
|
-3.89 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P200 amplitude at fz
|
—
|
—
|
1.662 microvolts
|
6.29 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P200 amplitude at cz
|
—
|
—
|
6.59 microvolts
|
7.8 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P50 S1 amplitude
|
—
|
—
|
2.76 microvolts
|
2.2 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
P50 S2 amplitude
|
—
|
—
|
1.23 microvolts
|
0.78 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
MMN amplitude at fz
|
—
|
—
|
-3.356 microvolts
|
-1.004 microvolts
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
MMN amplitude at cz
|
—
|
—
|
-4.13 microvolts
|
-1.322 microvolts
|
SECONDARY outcome
Timeframe: Recordings at baseline and week 6 of glycinePopulation: Only one subject received these procedures because normal hearing is required.
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.
Outcome measures
| Measure |
Glycine, Then Placebo
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
n=1 Participants
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
n=1 Participants
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
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
G40 fz
|
—
|
—
|
0.135 microvolts squared
|
0.255 microvolts squared
|
|
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
G40 cz
|
—
|
—
|
0.168 microvolts squared
|
0.29 microvolts squared
|
|
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
G20 fz
|
—
|
—
|
0.023 microvolts squared
|
0.107 microvolts squared
|
|
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
G20 cz
|
—
|
—
|
0.03 microvolts squared
|
0.108 microvolts squared
|
|
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
G30 fz
|
—
|
—
|
0.19 microvolts squared
|
0.177 microvolts squared
|
|
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
G30 cz
|
—
|
—
|
0.163 microvolts squared
|
0.242 microvolts squared
|
SECONDARY outcome
Timeframe: Recordings at baseline and week 6 of glycinePopulation: Only one subject received these procedures because normal hearing is required.
Auditory evoked potentials amplitude: P50 ratio (S2/S1). Participants were assessed at baseline and in week 6 of open-label glycine treatment.
Outcome measures
| Measure |
Glycine, Then Placebo
One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Placebo, Then Glycine
One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
|
Composite Score on Placebo
n=1 Participants
placebo, TID dosing, 6 weeks Double-blind
placebo
|
Composite Score on Glycine, Open-label
n=1 Participants
glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks
Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
|---|---|---|---|---|
|
Auditory Evoked Potentials - P50 Ratio (P50 S2/P50 S1 Amplitude) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT
|
—
|
—
|
44.51 ratio
|
35.67 ratio
|
Adverse Events
Glycine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glycine
n=2 participants at risk
Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks
glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
|
Placebo
n=2 participants at risk
placebo, TID dosing, 6 weeks
placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
100.0%
2/2 • 26 weeks
|
0.00%
0/2 • 26 weeks
|
|
Gastrointestinal disorders
vomiting
|
100.0%
2/2 • 26 weeks
|
0.00%
0/2 • 26 weeks
|
|
Gastrointestinal disorders
diarrhea
|
100.0%
2/2 • 26 weeks
|
0.00%
0/2 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place