Glycine vs Placebo for the Schizophrenia Prodrome

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia Prodrome

Treatments: Drug: Placebo; Drug: Glycine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00291226

0502027440

Details and patient eligibility

About

Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

Full description

A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Enrollment: 8 patients

Sex: All

Ages: 13 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• meet SIPS criteria for schizophrenia prodrome

Exclusion criteria

• history of psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Glycine

Experimental group

Description:

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 was dispensed under IND 33,515 (DCJ).

Treatment:

Drug: Glycine

Placebo Group

Placebo Comparator group

Description:

Placebo was dispensed as a proprietary formulations developed by Glytech, Inc, 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 placebo formulation, consisting of proprietary pre-flavored sugar powders to be dissolved in 8 ounces of water.

Treatment:

Drug: Placebo