Withdrawn

Phase 3
Age: 18Years - 65Years
All Genders
ID00000372

A Placebo Controlled Trial of Glycine Added to Clozapine in Schizophrenia

Led by Massachusetts General Hospital · Updated on 2014-06-12

N/A

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative symptoms (such as loss of interest, loss of energy, loss of warmth, and loss of humor) which occur between phases of positive symptoms (marked by hallucinations, delusions, and thought confusions) in schizophrenics. Clozapine is currently the most effective treatment for negative symptoms of schizophrenia. Two other drugs, D-cycloserine and glycine, are being investigated as new treatments. D-cycloserine improves negative symptoms when added to some drugs, but may worsen these symptoms when given with clozapine. Glycine also improves negative symptoms and may still be able to improve these symptoms when given with clozapine. This study gives either D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the best combination. Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the Global Assessment Scale. An individual may be eligible for this study if he/she is 18 to 65 years old and has been diagnosed with schizophrenia.

CONDITIONS

Official Title

Glycine and D-Cycloserine in Schizophrenia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Schizophrenia
  • Score of 27 or greater on the Scale for the Assessment of Negative Symptoms (SANS)
  • Treatment with stable dose of clozapine for at least 4 weeks
  • Between 18 and 65 years old
Not Eligible

You will not qualify if you...

  • No other antipsychotic medications in oral for for at least 3 months or in depot form for 6 months
  • Current major depressive episode
  • Current substance abuse diagnosis

Trial Site Locations

Total: 1 location

1

Freedom Trail Clinic

Boston, Massachusetts, United States, 02114

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Long-term clinical comparison of a resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions.

Uzay Koç-Vural, Leyla Kerimova-Köse, Arlin Kiremitci

https://pubmed.ncbi.nlm.nih.gov/38837034
A Placebo Controlled Trial of Glycine Added to Clozapine in Schizophrenia | DecenTrialz