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Glycine to Treat Psychotic Disorders in Children

NCT00005658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2008-03-04

No results posted yet for this study

Summary

This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication.

Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted.

Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood.

During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment:

1. Comprehensive psychiatric examination
2. Blood pressure and pulse monitoring once a week
3. Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels
4. Eye movement study at week eight - Using a technique called infrared oculography, special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor.
5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals.

Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed.

NIMH will follow patients by phone every six months and with visits at two-year intervals.

Conditions

Interventions

DRUG

Glycine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-31
Completion
2002-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005658 on ClinicalTrials.gov