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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532686
• Other study ID #: NSC-101-2314-B-039-030-MY3
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2015
• Last updated: January 29, 2018
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: January 2018
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• DAAOI-2
500-2000mg/d, oral, for 6 weeks
• placebo
oral, for 6 weeks

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale(PANSS)		baseline
Primary	Positive and Negative Syndrome Scale(PANSS)		2 weeks after the trial
Primary	Positive and Negative Syndrome Scale(PANSS)		4 weeks after the trial
Primary	Positive and Negative Syndrome Scale(PANSS)		6 weeks after the trial (The end of the trial)
Primary	Assessment of Negative symptoms(SANS)		baseline
Primary	Assessment of Negative symptoms(SANS)		2 weeks after the trial
Primary	Assessment of Negative symptoms(SANS)		4 weeks after the trial
Primary	Assessment of Negative symptoms(SANS)		6 weeks after the trial (The end of the trial)
Secondary	PANSS subscales		baseline
Secondary	PANSS subscales		2 weeks after the trial
Secondary	PANSS subscales		4 weeks after the trial
Secondary	PANSS subscales		6 weeks after the trial (The end of the trial)
Secondary	Clinical Global Impression (CGI)		baseline
Secondary	Clinical Global Impression (CGI)		2 weeks after the trial
Secondary	Clinical Global Impression (CGI)		4 weeks after the trial
Secondary	Clinical Global Impression (CGI)		6 weeks after the trial (The end of the trial)
Secondary	Global assessment of function (GAF)		baseline
Secondary	Global assessment of function (GAF)		2 weeks after the trial
Secondary	Global assessment of function (GAF)		4 weeks after the trial
Secondary	Global assessment of function (GAF)		6 weeks after the trial (The end of the trial)
Secondary	Hamilton Depression Rating Scale (HAMD)		baseline
Secondary	Hamilton Depression Rating Scale (HAMD)		2 weeks after the trial
Secondary	Hamilton Depression Rating Scale (HAMD)		4 weeks after the trial
Secondary	Hamilton Depression Rating Scale (HAMD)		6 weeks after the trial (The end of the trial)
Secondary	Quality of life scale (QOL)		baseline
Secondary	Quality of life scale (QOL)		2 weeks after the trial
Secondary	Quality of life scale (QOL)		4 weeks after the trial
Secondary	Quality of life scale (QOL)		6 weeks after the trial (The end of the trial)
Secondary	"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]	An intergrated score from 7 domains: speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); sustained attention: continuous performance test; verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); verbal learning and memory: word listing from WMS-III; visual learning and memory: visual reproduction from WMS-III; reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)	baseline
Secondary	"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]	An intergrated score from 7 domains: speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); sustained attention: continuous performance test; verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); verbal learning and memory: word listing from WMS-III; visual learning and memory: visual reproduction from WMS-III; reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)	6 weeks after the trial (The end of the trial)