Trial Outcomes & Findings for Biomarkers in Schizophrenia (NCT NCT00817336)

Results Overview

Positive and Negative Symptom Scale (PANSS) range 30-210

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	D-serine Followed by Placebo subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.	Placebo Followed by D-serine subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	D-serine Followed by Placebo subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.	Placebo Followed by D-serine subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Biomarkers in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-serine Followed by Placebo n=7 Participants Does not include 1 drop-out during phase 1	Placebo Followed by D-serine n=7 Participants Does not include 1 drop-out during phase 1	Total n=14 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=99 Participants	44.6 years STANDARD_DEVIATION 11 • n=107 Participants	40 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	7 Participants n=107 Participants	13 Participants n=206 Participants
In-patient number	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Chlorpromazine equivalents	1135 mg STANDARD_DEVIATION 967 • n=99 Participants	795 mg STANDARD_DEVIATION 496 • n=107 Participants	965 mg STANDARD_DEVIATION 760 • n=206 Participants
PANSS total	83.7 units on a scale STANDARD_DEVIATION 9 • n=99 Participants	80.1 units on a scale STANDARD_DEVIATION 10 • n=107 Participants	80.8 units on a scale STANDARD_DEVIATION 8.4 • n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Final score end of six weeks

Positive and Negative Symptom Scale (PANSS) range 30-210

Outcome measures

Outcome measures
Measure	D-serine n=14 Participants 60 mg/kg/day D Serine: 60 mg/kg/day	Placebo n=14 Participants Placebo: oral
PANSS Total	77.9 units on a scale Standard Deviation 9.3	80 units on a scale Standard Deviation 10.3

PRIMARY outcome

Timeframe: 6 weeks

Population: Includes 11 subjects with analyzable MMN data

Final MMN amplitude

Outcome measures

Outcome measures
Measure	D-serine n=11 Participants 60 mg/kg/day D Serine: 60 mg/kg/day	Placebo n=11 Participants Placebo: oral
MMN Amplitude	-1.21 micro volts Standard Deviation .6	-.21 micro volts Standard Deviation .9

SECONDARY outcome

Timeframe: 6 weeks

Population: Final score after six weeks

MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.

Outcome measures

Outcome measures
Measure	D-serine n=14 Participants 60 mg/kg/day D Serine: 60 mg/kg/day	Placebo n=14 Participants Placebo: oral
MATRICS	26.2 T score Standard Deviation 7.6	25.7 T score Standard Deviation 7.9

SECONDARY outcome

Timeframe: 6 weeks

Population: includes subjecst with valid visual p1 data

Outcome measures

Outcome measures
Measure	D-serine n=12 Participants 60 mg/kg/day D Serine: 60 mg/kg/day	Placebo n=12 Participants Placebo: oral
Visual P1	-.21 micro volts Standard Deviation 1.3	-.54 micro volts Standard Deviation 1.2

Adverse Events

D-serine/Placebo Crossover

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua Kantrowitz

Nathan Kline Institute

Phone: 646-774-6738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place