Psychotic DisorderPhase 2NCT00005658
Glycine to Treat Psychotic Disorders in Children
A Phase 2 study testing Glycine in people with Psychotic Disorder and Schizoaffecitve Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychotic Disorder, Schizoaffecitve Disorder, Schizophrenia
- What is being tested?
- Glycine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Jan 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Childhood Onset Psychotic Disorders: An Open Trial With the Amino Acid Glycine
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.
Read more
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:
- Comprehensive psychiatric examination
- Blood pressure and pulse monitoring once a week
- Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels
- 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.
- 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.
Read the detailed description
The ability of glycine to potentiate the NMDA receptor-complex, along with the fact that it is well tolerated in short-and long-term administration, has raised the possibility that it may provide an effective treatment of augmentation for neuroleptic-resistant negative symptoms of schizophrenia. Up to ten children and adolescents, ages 9-18, meeting DSM-IV criteria for schizophrenia, schizoaffective disorder and psychotic disorder not otherwise specified with onset of psychosis by age 12 who have failed at least two prior antipsychotics entering this protocol on their current antipsychotic medication(s) will participate in an open 8-week trial of adjunctive glycine therapy. In addition to the potential benefits, if glycine therapy ameliorates enduring negative symptoms of schizophrenia, we anticipate that recruiting these rare patients will be facilitated by the availability of this new treatment.
This study will provide pilot data regarding the beneficial effects and safety of adjunctive glycine therapy for children and adolescents with treatment refractory psychotic disorders. The availability of newer alternate treatments is also important for recruitment of patients in the broader study of the neurobiology and genetics of very early onset schizophrenia.
Children and adolescents ages nine to eighteen will be allowed into the study. Subjects entering the protocol as new patients will be characterized by clinical phenomenology, eye tracking, MRI brain imaging, cerebrospinal fluid, plasma and urinary biochemistry, and chromosomal analysis. Patients with prominent mood symptoms who have required the addition of mood stabilizing agents such as lithium or valproic acid will be allowed to remain on these medications for the duration of the treatment trial, if clinically indicated. Liver chemistries will be checked at baseline and at the end of the study.
All first-degree relatives are interviewed in person and undergo eye tracking measurement and contribute blood cell lines as part of a genetic study of the cohort (84-M-0050).
- Conditions
- Psychotic Disorder, Schizoaffecitve Disorder, Schizophrenia
- Being tested
- Glycine
- Keywords
- Biochemical, Schizophrenia, NMDA, Adolescence, Psychosis, Child Psychosis, Biochemical Correlates, Brain Imaging, Glycine, Adjunctive Glycine Therapy
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2000 (estimated)
- Study startMay 2000
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005658
- Sponsor's protocol ID
- 000122
- Other IDs
- 00-M-0122
- Status last verified
- Jan 2002
- First submitted
- 9 May 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 2793800Alaghband-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.
PubMed 7592264Frazier 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.
PubMed 8599409
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Onset Psychotic Disorders: An Open Trial With the Amino Acid Glycine
- ClinicalTrials.gov ID
- NCT00005658
- Acronym / sponsor ID
- 000122
- Conditions
- Psychotic Disorder, Schizoaffecitve Disorder, Schizophrenia
- Keywords
- Biochemical, Schizophrenia, NMDA, Adolescence, Psychosis, Child Psychosis, Biochemical Correlates, Brain Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- May 2000
- Study completion
- Jan 2002
- First posted
- 10 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Comprehensive psychiatric examination
- Blood pressure and pulse monitoring once a week
- Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels
- 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.
- 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.
Detailed description
The ability of glycine to potentiate the NMDA receptor-complex, along with the fact that it is well tolerated in short-and long-term administration, has raised the possibility that it may provide an effective treatment of augmentation for neuroleptic-resistant negative symptoms of schizophrenia. Up to ten children and adolescents, ages 9-18, meeting DSM-IV criteria for schizophrenia, schizoaffective disorder and psychotic disorder not otherwise specified with onset of psychosis by age 12 who have failed at least two prior antipsychotics entering this protocol on their current antipsychotic medication(s) will participate in an open 8-week trial of adjunctive glycine therapy. In addition to the potential benefits, if glycine therapy ameliorates enduring negative symptoms of schizophrenia, we anticipate that recruiting these rare patients will be facilitated by the availability of this new treatment.
This study will provide pilot data regarding the beneficial effects and safety of adjunctive glycine therapy for children and adolescents with treatment refractory psychotic disorders. The availability of newer alternate treatments is also important for recruitment of patients in the broader study of the neurobiology and genetics of very early onset schizophrenia.
Children and adolescents ages nine to eighteen will be allowed into the study. Subjects entering the protocol as new patients will be characterized by clinical phenomenology, eye tracking, MRI brain imaging, cerebrospinal fluid, plasma and urinary biochemistry, and chromosomal analysis. Patients with prominent mood symptoms who have required the addition of mood stabilizing agents such as lithium or valproic acid will be allowed to remain on these medications for the duration of the treatment trial, if clinically indicated. Liver chemistries will be checked at baseline and at the end of the study.
All first-degree relatives are interviewed in person and undergo eye tracking measurement and contribute blood cell lines as part of a genetic study of the cohort (84-M-0050).
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 2793800Ambrosini 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.
- Background: PubMed 7592264Alaghband-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.
- Background: PubMed 8599409Frazier 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.
Related trials for Psychotic Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycine in people with Psychotic Disorder and Schizoaffecitve Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.