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

China Medical University

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: DAAOI-2; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02532686

NSC-101-2314-B-039-030-MY3

Details and patient eligibility

About

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, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. 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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Agree to participate in the study and provide informed consent

Exclusion criteria

• 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
• Inability to follow protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

DAAOI-2

Experimental group

Description:

DAAOI-2: 500-2000mg/d

Treatment:

Drug: DAAOI-2

placebo

Placebo Comparator group

Treatment:

Drug: placebo