Trial Outcomes & Findings for Glycine vs Placebo for the Schizophrenia Prodrome (NCT NCT00291226)

Last Updated: 2020-04-02

Results Overview

Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Baseline

Results posted on

2020-04-02

Participant Flow

Subjects were enrolled between March 2006 and May 2008. Potential subjects or their families or providers were informed about the symptoms of the risk syndrome for psychosis through a variety of ongoing community education efforts and were invited to call our research clinic if concerned.

Exclusions: 1) past or current DSM IV criteria for any lifetime psychotic disorder, 2) alcohol or drug abuse or dependence in the past three months, 3) use of antipsychotic medication in the previous three months, 4) change in dosage of any antidepressant, anxiolytic, psychostimulant, or mood stabilizer medication within eight weeks.

Participant milestones

Participant milestones
Measure	Glycine Glycine dosing group.	Placebo Group Glycine and placebo dosing group.
Overall Study STARTED	4	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glycine vs Placebo for the Schizophrenia Prodrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glycine n=4 Participants Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Glycine: Glycine 0.4 g/kg bid	Placebo Group n=4 Participants Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water. Placebo: Placebo	Total n=8 Participants Total of all reporting groups
Age, Continuous	15.3 years STANDARD_DEVIATION 0.5 • n=5 Participants	16.5 years STANDARD_DEVIATION 2.4 • n=7 Participants	15.9 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Glycine n=4 Participants Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Glycine: Glycine 0.4 g/kg bid	Placebo Group n=4 Participants Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water. Placebo: Placebo
Scale of Prodromal Symptoms Total Score	37.8 units on a scale Standard Deviation 15.3	37.5 units on a scale Standard Deviation 10.0

PRIMARY outcome

Timeframe: Change from Baseline at 8 Weeks

Outcome measures

Outcome measures
Measure	Glycine n=4 Participants Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Glycine: Glycine 0.4 g/kg bid	Placebo Group n=4 Participants Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water. Placebo: Placebo
Change in Scale of Prodromal Symptoms Total Score	-5.8 units on a scale Standard Deviation 8.1	4.5 units on a scale Standard Deviation 9.7

Adverse Events

Glycine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Glycine n=4 participants at risk Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Glycine: Glycine 0.4 g/kg bid	Placebo Group n=4 participants at risk Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water. Placebo: Placebo
Psychiatric disorders Irritability	0.00% 0/4	25.0% 1/4 • Number of events 1
Psychiatric disorders Sedation	0.00% 0/4	50.0% 2/4 • Number of events 2
Reproductive system and breast disorders Orgasm Dysfunction	25.0% 1/4 • Number of events 1	0.00% 0/4
General disorders Disturbed Sleep	0.00% 0/4	50.0% 2/4 • Number of events 2
General disorders Malaise	0.00% 0/4	25.0% 1/4 • Number of events 1
Psychiatric disorders Mentation Impaired	0.00% 0/4	25.0% 1/4 • Number of events 1
Psychiatric disorders Hallucinations	0.00% 0/4	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Stomach Discomfort	0.00% 0/4	25.0% 1/4 • Number of events 1

Additional Information

Scott W. Woods, MD

Yale University School of Medicine

Phone: 203-974-7038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place