Trial Outcomes & Findings for Safety and Effectiveness of D-serine in Schizophrenia (NCT NCT00322023)
NCT ID: NCT00322023
Last Updated: 2020-10-05
Results Overview
number of renal adverse events (serum and urinalysis)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Measured at Week 4
Results posted on
2020-10-05
Participant Flow
Nathan Kline Institute, Yale University, Zucker Hillside
Participant milestones
| Measure |
D-serine 30 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
D-serine 60 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
D Serine 120 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
21
|
22
|
|
Overall Study
COMPLETED
|
12
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
6
|
Reasons for withdrawal
| Measure |
D-serine 30 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
D-serine 60 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
D Serine 120 mg/kg
Open label, adjunctive to antipsychotics for 4 weeks
|
|---|---|---|---|
|
Overall Study
various
|
0
|
2
|
6
|
Baseline Characteristics
Safety and Effectiveness of D-serine in Schizophrenia
Baseline characteristics by cohort
| Measure |
D-serine 30 mg/kg
n=12 Participants
|
D-serine 60 mg/kg
n=21 Participants
|
D Serine 120 mg/kg
n=22 Participants
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
43.9 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
43.2 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
43 years
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 4Population: study completers
number of renal adverse events (serum and urinalysis)
Outcome measures
| Measure |
D-serine 30 mg/kg
n=12 Participants
4 weeks of adjunctive treatment
|
D-serine 60 mg/kg
n=19 Participants
4 weeks of adjunctive treatment
|
D Serine 120 mg/kg
n=16 Participants
4 weeks of adjunctive treatment
|
|---|---|---|---|
|
Renal Safety Measures
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
SECONDARY outcome
Timeframe: Measured at Week 4Population: Study completers
Absolute Change in PANSS over four weeks (change between baseline and final measurements). The PANSS is a 30-item rating scale widely used in assessment of medication effects in schizophrenia. The PANSS ranges from 30-210, with lower scores showing less symptoms. Larger change is better.
Outcome measures
| Measure |
D-serine 30 mg/kg
n=12 Participants
4 weeks of adjunctive treatment
|
D-serine 60 mg/kg
n=19 Participants
4 weeks of adjunctive treatment
|
D Serine 120 mg/kg
n=16 Participants
4 weeks of adjunctive treatment
|
|---|---|---|---|
|
Positive and Negative Symptoms Scale (PANSS)
|
5.1 units on a scale
Standard Deviation 5.3
|
4.4 units on a scale
Standard Deviation 8.9
|
6.3 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Measured at Week 4Population: study completers
Change over 4 weeks. The MATRICS is a scale measuring cognition, and reported as T-score, with 50 as the population average and every 10 points representing a change of 1 standard deviation from the population average. Higher scores represent an improvement
Outcome measures
| Measure |
D-serine 30 mg/kg
n=12 Participants
4 weeks of adjunctive treatment
|
D-serine 60 mg/kg
n=19 Participants
4 weeks of adjunctive treatment
|
D Serine 120 mg/kg
n=16 Participants
4 weeks of adjunctive treatment
|
|---|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery
|
0.8 units on a scale
Standard Deviation 3.0
|
3.9 units on a scale
Standard Deviation 3.5
|
2.8 units on a scale
Standard Deviation 2.8
|
Adverse Events
D-serine 30 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D-serine 60 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D Serine 120 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D-serine 30 mg/kg
n=12 participants at risk
4 weeks of adjunctive treatment
|
D-serine 60 mg/kg
n=19 participants at risk
4 weeks of adjunctive treatment
|
D Serine 120 mg/kg
n=16 participants at risk
4 weeks of adjunctive treatment
|
|---|---|---|---|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12
|
0.00%
0/19
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
D-serine 30 mg/kg
n=12 participants at risk
4 weeks of adjunctive treatment
|
D-serine 60 mg/kg
n=19 participants at risk
4 weeks of adjunctive treatment
|
D Serine 120 mg/kg
n=16 participants at risk
4 weeks of adjunctive treatment
|
|---|---|---|---|
|
Hepatobiliary disorders
asymptomatic transaminitis
|
0.00%
0/12
|
0.00%
0/19
|
12.5%
2/16 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place