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NCT00005658 · ClinicalTrials.gov registry record · Phase 2
Glycine to Treat Psychotic Disorders in Children
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00005658: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00005658 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005658, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
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
Interventions
- DRUG Glycine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2000-05 |
| Est. Completion | 2002-01 |
| Phase | Phase 2 |
What the finished NCT00005658 record still lists
NCT00005658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Glycine is the first listed.
NCT00005658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005658 about?
NCT00005658 is a clinical study titled "Glycine to Treat Psychotic Disorders in Children". 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...
What is the current status of trial NCT00005658?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2000-05. Estimated completion is 2002-01.
What interventions are being tested in trial NCT00005658?
The interventions under investigation include: Glycine (DRUG).
Who is sponsoring clinical trial NCT00005658?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005658's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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