NCT02532686

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

August 10, 2015

Last Update Submit

January 29, 2018

Conditions

Schizophrenia

Keywords

Treatment resistantDAAOINMDA

Outcome Measures

Primary Outcomes (8)

  • Positive and Negative Syndrome Scale(PANSS)

    baseline

  • Positive and Negative Syndrome Scale(PANSS)

    2 weeks after the trial

  • Positive and Negative Syndrome Scale(PANSS)

    4 weeks after the trial

  • Positive and Negative Syndrome Scale(PANSS)

    6 weeks after the trial (The end of the trial)

  • Assessment of Negative symptoms(SANS)

    baseline

  • Assessment of Negative symptoms(SANS)

    2 weeks after the trial

  • Assessment of Negative symptoms(SANS)

    4 weeks after the trial

  • Assessment of Negative symptoms(SANS)

    6 weeks after the trial (The end of the trial)

Secondary Outcomes (22)

  • PANSS subscales

    baseline

  • PANSS subscales

    2 weeks after the trial

  • PANSS subscales

    4 weeks after the trial

  • PANSS subscales

    6 weeks after the trial (The end of the trial)

  • Clinical Global Impression (CGI)

    baseline

  • +17 more secondary outcomes

Study Arms (2)

DAAOI-2

EXPERIMENTAL

DAAOI-2: 500-2000mg/d

Drug: DAAOI-2

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

DAAOI-2DRUG

500-2000mg/d, oral, for 6 weeks

DAAOI-2
placeboDRUG

oral, for 6 weeks

placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychiatry

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 26, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

TW(1)