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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DAAOI-2
placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Treatment resistant, DAAOI, NMDA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Psychiatry, China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAAOI-2

placebo

Arm Description

DAAOI-2: 500-2000mg/d

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale(PANSS)
Positive and Negative Syndrome Scale(PANSS)
Positive and Negative Syndrome Scale(PANSS)
Positive and Negative Syndrome Scale(PANSS)
Assessment of Negative symptoms(SANS)
Assessment of Negative symptoms(SANS)
Assessment of Negative symptoms(SANS)
Assessment of Negative symptoms(SANS)

Secondary Outcome Measures

PANSS subscales
PANSS subscales
PANSS subscales
PANSS subscales
Clinical Global Impression (CGI)
Clinical Global Impression (CGI)
Clinical Global Impression (CGI)
Clinical Global Impression (CGI)
Global assessment of function (GAF)
Global assessment of function (GAF)
Global assessment of function (GAF)
Global assessment of function (GAF)
Hamilton Depression Rating Scale (HAMD)
Hamilton Depression Rating Scale (HAMD)
Hamilton Depression Rating Scale (HAMD)
Hamilton Depression Rating Scale (HAMD)
Quality of life scale (QOL)
Quality of life scale (QOL)
Quality of life scale (QOL)
Quality of life scale (QOL)
"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)
"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)

Full Information

First Posted
August 10, 2015
Last Updated
January 29, 2018
Sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02532686
Brief Title
DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
Official Title
DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Treatment resistant, DAAOI, NMDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAAOI-2
Arm Type
Experimental
Arm Description
DAAOI-2: 500-2000mg/d
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DAAOI-2
Intervention Description
500-2000mg/d, oral, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral, for 6 weeks
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale(PANSS)
Time Frame
baseline
Title
Positive and Negative Syndrome Scale(PANSS)
Time Frame
2 weeks after the trial
Title
Positive and Negative Syndrome Scale(PANSS)
Time Frame
4 weeks after the trial
Title
Positive and Negative Syndrome Scale(PANSS)
Time Frame
6 weeks after the trial (The end of the trial)
Title
Assessment of Negative symptoms(SANS)
Time Frame
baseline
Title
Assessment of Negative symptoms(SANS)
Time Frame
2 weeks after the trial
Title
Assessment of Negative symptoms(SANS)
Time Frame
4 weeks after the trial
Title
Assessment of Negative symptoms(SANS)
Time Frame
6 weeks after the trial (The end of the trial)
Secondary Outcome Measure Information:
Title
PANSS subscales
Time Frame
baseline
Title
PANSS subscales
Time Frame
2 weeks after the trial
Title
PANSS subscales
Time Frame
4 weeks after the trial
Title
PANSS subscales
Time Frame
6 weeks after the trial (The end of the trial)
Title
Clinical Global Impression (CGI)
Time Frame
baseline
Title
Clinical Global Impression (CGI)
Time Frame
2 weeks after the trial
Title
Clinical Global Impression (CGI)
Time Frame
4 weeks after the trial
Title
Clinical Global Impression (CGI)
Time Frame
6 weeks after the trial (The end of the trial)
Title
Global assessment of function (GAF)
Time Frame
baseline
Title
Global assessment of function (GAF)
Time Frame
2 weeks after the trial
Title
Global assessment of function (GAF)
Time Frame
4 weeks after the trial
Title
Global assessment of function (GAF)
Time Frame
6 weeks after the trial (The end of the trial)
Title
Hamilton Depression Rating Scale (HAMD)
Time Frame
baseline
Title
Hamilton Depression Rating Scale (HAMD)
Time Frame
2 weeks after the trial
Title
Hamilton Depression Rating Scale (HAMD)
Time Frame
4 weeks after the trial
Title
Hamilton Depression Rating Scale (HAMD)
Time Frame
6 weeks after the trial (The end of the trial)
Title
Quality of life scale (QOL)
Time Frame
baseline
Title
Quality of life scale (QOL)
Time Frame
2 weeks after the trial
Title
Quality of life scale (QOL)
Time Frame
4 weeks after the trial
Title
Quality of life scale (QOL)
Time Frame
6 weeks after the trial (The end of the trial)
Title
"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]
Description
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)
Time Frame
baseline
Title
"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]
Description
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)
Time Frame
6 weeks after the trial (The end of the trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Psychiatry, China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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

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