Glycine to Treat Psychotic Disorders in Children

NCT00005658 | Completed Phase 2

• 2 other identifiers: 00012200-M-0122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.Comprehensive psychiatric examination
2. 2.Blood pressure and pulse monitoring once a week
3. 3.Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels
4. 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. 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during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals.

Conditions

Psychotic Disorder; Schizoaffecitve Disorder; Schizophrenia

Keywords

Biochemical; Schizophrenia; NMDA; Adolescence; Psychosis; Child Psychosis; Biochemical Correlates; Brain Imaging; Glycine; Adjunctive Glycine Therapy

Interventions

Glycine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Patients with their psychosis in a moderate to severe range defined as a SANS score of 5 or above, a SAPS score of 5 or above and/or a BPRS score of 30 or above. Males and females, age 9-18 meeting DSM-IV criteria for schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified with onset of psychosis before their 13th birthday. Patients must have had their 9th birthday by the end of drug washout. Patients with failure of two prior antipsychotic treatments, or discontinuation of effective clozapine or olanzapine treatment due to intolerable side effects. Patients with a premorbid IQ test less than 70. No patients with any significant neurological/medical disorder; and/or active alcohol or drug abuse. No patients judged to be at serious suicidal risk. Females who are physically capable of pregnancy must agree to avoid pregnancy throughout the study. Should pregnancy occur during the study, the patient will be unable to continue. MRI exam will not be given to patients with any metal prostheses, surgical clips, or other metal implants, or cannot tolerate the procedure.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ambrosini PJ, Metz C, Prabucki K, Lee JC. Videotape reliability of the third revised edition of the K-SADS. J Am Acad Child Adolesc Psychiatry. 1989 Sep;28(5):723-8. doi: 10.1097/00004583-198909000-00013.

  PMID: 2793800 BACKGROUND

• Alaghband-Rad J, McKenna K, Gordon CT, Albus KE, Hamburger SD, Rumsey JM, Frazier JA, Lenane MC, Rapoport JL. Childhood-onset schizophrenia: the severity of premorbid course. J Am Acad Child Adolesc Psychiatry. 1995 Oct;34(10):1273-83. doi: 10.1097/00004583-199510000-00012.

  PMID: 7592264 BACKGROUND

• Frazier JA, Giedd JN, Kaysen D, Albus K, Hamburger S, Alaghband-Rad J, Lenane MC, McKenna K, Breier A, Rapoport JL. Childhood-onset schizophrenia: brain MRI rescan after 2 years of clozapine maintenance treatment. Am J Psychiatry. 1996 Apr;153(4):564-6. doi: 10.1176/ajp.153.4.564.

  PMID: 8599409 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Glycine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 9, 2000
• First Posted: May 10, 2000
• Study Start: May 1, 2000
• Study Completion: January 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-01

Locations

US (1)