Completed

DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia

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What is being tested

DAAOI-2

+ placebo

Drug
Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2014
See protocol details

Summary

Principal SponsorChina Medical University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2014

Actual date on which the first participant was enrolled.

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Official TitleDAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
NCT02532686
Principal SponsorChina Medical University Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

5 inclusion criteria required to participate
Fulfill the DSM-IV criteria of schizophrenia
Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
Show More Criteria
5 exclusion criteria prevent from participating
Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
Meet DSM-IV criteria of mental retardation
Serious medical or neurological illness
Pregnancy or lactation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
DAAOI-2: 500-2000mg/d

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Psychiatry, China Medical University Hospital

Taichung, TaiwanOpen Department of Psychiatry, China Medical University Hospital in Google Maps
CompletedOne Study Center
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