NCT00960219

Brief Summary

Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 11, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

August 14, 2009

Last Update Submit

July 7, 2011

Conditions

SchizophreniasPsychosesPsychotic DisordersSchizophrenic Disorders

Outcome Measures

Primary Outcomes (2)

  • Total scores of PANSS, SANS, GAF, and QOL

    week 0, 2, 4, 6.

  • Cognitive function

    MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia), including:1) speed of processing;(2) sustained attention; 3) working memory, verbal and nonverbal; 4) verbal learning and memory; 5) visual learning and memory; 6) reasoning and problem solving, and 7) social cognition

    Week 0, 6

Secondary Outcomes (3)

  • The subscales of PANSS

    week 0,2,4,6

  • Hamilton Depression rating scale 17(HAM-D 17)

    Week 0, 2, 4, 6

  • Clinical Global Impression(CGI)

    Week 0, 2, 4, 6

Study Arms (2)

DAAOI-1

EXPERIMENTAL
Drug: D-amino acid oxidase inhibition (DAAOI-1)

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

D-amino acid oxidase inhibition (DAAOI-1)DRUG

1g/day(500mg BID), oral, for 6 weeks

Also known as: DAAOI-1
DAAOI-1
placeboDRUG

1# BID, oral, for 6 weeks

Also known as: starch
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
  • Aged 18-65 year
  • Fulfill the criteria of schizophrenia according to the Diagnostic and Statistical Manual, fourth edition (DSM-IV)
  • 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 60 on the Positive and Negative Syndrome Scale (PANSS)
  • Agree to participate in the study and provide informed consent

You may not qualify if:

  • DSM-IV diagnosis of substance (including alcohol) abuse or dependence,
  • DSM\_IV diagnosis of mental retardation
  • History of epilepsy, head trauma or CNS diseases
  • History of epilepsy, head trauma or CNS diseases
  • Pregnancy or lactation
  • Inability to follow protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (1)

  • Lane HY, Lin CH, Green MF, Hellemann G, Huang CC, Chen PW, Tun R, Chang YC, Tsai GE. Add-on treatment of benzoate for schizophrenia: a randomized, double-blind, placebo-controlled trial of D-amino acid oxidase inhibitor. JAMA Psychiatry. 2013 Dec;70(12):1267-75. doi: 10.1001/jamapsychiatry.2013.2159.

    PMID: 24089054DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Starch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Hsien-Yuan Lane, M.D., Ph.D

    Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 11, 2011

Record last verified: 2011-07

Locations

TW(1)