Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia

Status Completed

Clinical Trial Summary

Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.

Clinical Trial Description

We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.

To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Schizophrenia

Clinical Trial Details

NCT number	NCT01047592
Study type	Interventional
Source	Chang-Hua Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	March 2009
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05039489` - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT04503954` - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia	N/A
Completed	`NCT02831231` - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium	Phase 1
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Completed	`NCT03652974` - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy	Phase 4
Recruiting	`NCT04012684` - rTMS on Mismatch Negativity of Schizophrenia	N/A
Recruiting	`NCT04481217` - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT00212784` - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)	Phase 3
Completed	`NCT04092686` - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia	Phase 3
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Recruiting	`NCT03790345` - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	Phase 2/Phase 3
Recruiting	`NCT05956327` - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training	N/A
Terminated	`NCT03209778` - Involuntary Memories Investigation in Schizophrenia	N/A
Terminated	`NCT03261817` - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders	N/A
Completed	`NCT02905604` - Magnetic Stimulation of the Brain in Schizophrenia or Depression	N/A
Recruiting	`NCT05542212` - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia	N/A
Completed	`NCT04411979` - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia	N/A
Terminated	`NCT03220438` - TMS Enhancement of Visual Plasticity in Schizophrenia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.