NCT01251055

Brief Summary

The etiology of schizophrenia remains unclear In recent one decade, hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for schizophrenia treatment. To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to NMDA enhancers.

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 Apr 2010

Typical duration for phase_2 schizophrenia

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, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

3.5 years

First QC Date

November 3, 2010

Last Update Submit

October 27, 2013

Conditions

SchizophreniaTreatment Refractory

Keywords

N-methyl-D-aspartate receptorglycine transporterschizophrenia

Outcome Measures

Primary Outcomes (4)

  • The severity of psychiatric symptoms

    The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)

    baseline

  • The severity of psychiatric symptoms

    The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)

    2 weeks after the trial

  • The severity of psychiatric symptoms

    The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)

    4 weeks after the trial

  • The severity of psychiatric symptoms

    The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF)

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

Secondary Outcomes (6)

  • Neurocognitive Function

    baseline

  • Neurocognitive function

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

  • The severity of psychiatric symptoms

    baseline

  • The severity of psychiatric symptoms

    2 weeks after the trial

  • The severity of psychiatric symptoms

    4 weeks after the trial

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

GlyT-1 inhibitor-1

EXPERIMENTAL

GlyT-1 inhibitor-1 4000 mg/day

Drug: GlyT-1 inhibitor-1

Interventions

GlyT-1 inhibitor-1DRUG

GlyT-1 inhibitor-1(500) 4# BID

GlyT-1 inhibitor-1
PlaceboDRUG

starch

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
  • Poor response of clozapine treatment: a 12-week treatment of clozapine without satisfactory response: a severity score of Clinical Global Impression Scale(CGI)\>=4, a total score of Positive and Negative Syndrome Scale(PANSS)\>= 60, and a Scale for the Assessment of Negative Symptoms(SANS)score of \>=40. the doses of clozapine remain stable for at least 12 weeks prior to their enrollment in this proposed study,
  • Agree to participate in the study and provide informed consent.

You may not qualify if:

  • current substance abuse or history of substance dependence in the past 6 months
  • use of depot antipsychotic in the past 6 months
  • serious medical or neurological illness
  • pregnancy
  • inability to follow protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 400, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hsien-Yuan Lane, MD.PhD.

    Department of Psychiatry, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2010

First Posted

December 1, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

TW(1)