Trial Outcomes & Findings for D-serine for the Schizophrenia Prodrome (NCT NCT00826202)

Results Overview

The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

16 weeks

Results posted on

2017-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	D Serine 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo Placebo: Inert Placebo
Overall Study STARTED	20	24
Overall Study Completed Visit 4 (1st Efficacy Visit)	15	20
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-serine for the Schizophrenia Prodrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D Serine n=15 Participants 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=20 Participants Placebo: Inert Placebo	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20 years STANDARD_DEVIATION 4.9 • n=5 Participants	19 years STANDARD_DEVIATION 3.5 • n=7 Participants	19.5 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	20 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.

Outcome measures

Outcome measures
Measure	D Serine n=15 Participants 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=20 Participants Placebo: Inert Placebo
Scale of Prodromal Symptoms (SOPS) Negative Scale	7.6 SOPS negative final score Standard Deviation 1.4	11.3 SOPS negative final score Standard Deviation 1.2

SECONDARY outcome

Timeframe: 16 weeks

The SOPS Total consists of five Positive Symptom items, six Negative Symptom items, four Disorganization Symptom items, and four General Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme-and Psychotic, for the positive items). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 114.

Outcome measures

Outcome measures
Measure	D Serine n=15 Participants 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=20 Participants Placebo: Inert Placebo
Scale of Prodromal Symptoms (SOPS) Total	23.9 units on a scale Standard Deviation 2.8	30.5 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 16 weeks

Final IL6 levels (pg/ml) in available subjects

Outcome measures

Outcome measures
Measure	D Serine n=11 Participants 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=16 Participants Placebo: Inert Placebo
IL6 Levels	.49 final IL6 level (pg/ml)) Standard Deviation .25	.79 final IL6 level (pg/ml)) Standard Deviation .52

SECONDARY outcome

Timeframe: 16 weeks

Population: Completers at NYSPI and NKI sites

The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and five questions rated by the bed partner or roommate. The latter five questions are used for clinical information only, are not tabulated in the scoring of the PSQI. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores

Outcome measures

Outcome measures
Measure	D Serine n=8 Participants 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=11 Participants Placebo: Inert Placebo
Pittsburgh Sleep Quality Index Score	4 final score Standard Deviation 2.9	7.7 final score Standard Deviation 3.5

Adverse Events

D Serine

Serious events: 1 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

Serious adverse events
Measure	D Serine n=20 participants at risk 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=24 participants at risk Placebo: Inert Placebo
Psychiatric disorders suicidal thoughts-hospitalization	5.0% 1/20 • Number of events 1	0.00% 0/24

Other adverse events

Other adverse events
Measure	D Serine n=20 participants at risk 60 mg/kg/day D-serine: 60 mg/kg/day	Placebo n=24 participants at risk Placebo: Inert Placebo
Renal and urinary disorders Out of range renal values	10.0% 2/20 • Number of events 2	0.00% 0/24

Additional Information

Daniel Javitt MD, PhD

Nathan Kline Institute

Phone: 845-398-6534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place