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NCT01720316 · ClinicalTrials.gov registry record · Phase 2
Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders
A Phase 2 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01720316 is a Phase 2 study that has completed, run by Mclean Hospital. The registered enrollment target is 2 participants.
The verdict
NCT01720316, a Phase 2 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of oral glycine as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the gene glycine decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week period of no treatment will occur between treatment arms. A 6-week period of open-label glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow the double-blind placebo-controlled clinical trial. Prior to the double-blind placebo-controlled clinical trial and at the end of the open-label glycine trial, the following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T), steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital Pharmacy. Because the results of the double-blind placebo-controlled and open-label glycine treatment arms showed substantial clinical benefit to the participants, the study has been extended to include six months of chronic open-label glycine in order to determine 1) whether the clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this extension will be provided by Letco Medical. The investigators hypothesize that mutation carriers will have reduced endogenous bra
Interventions
- DRUG placebo
- DRUG Glycine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-12-10 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01720316
The ClinicalTrials.gov registry entry for NCT01720316 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01720316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01720316 about?
NCT01720316 is a clinical study titled "Neurobiology of a Mutation in Glycine Metabolism in Psychotic Disorders". The purpose of this study is to assess the efficacy of oral glycine as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the gene glycine decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical trial in which one 6-week arm will...
What is the current status of trial NCT01720316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2012-12-10. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT01720316?
The interventions under investigation include: placebo (DRUG), Glycine (DRUG).
Who is sponsoring clinical trial NCT01720316?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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