NCT01116830

Brief Summary

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams \[mg\] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1 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

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 4, 2010

Last Update Submit

November 1, 2016

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

  • Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)

    Baseline, Week 6

  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG

    Baseline, Week 6

  • Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG

    Baseline, Week 6

  • Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG

    Baseline, Week 6

  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG

    Baseline, Week 6

Secondary Outcomes (13)

  • Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG

    Baseline, Week 1

  • Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG

    Baseline, Week 1

  • Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG

    Baseline, Week 1

  • Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG

    Baseline, Week 1

  • Positive Predictive Value of Cognitive Dysfunction Biomarkers (Mismatch Negativity, ERP, N1 Refractoriness, P3 Component, and VEP) Change at Week 1 to Predict the Presence of Biomarker Response at Week 6, as Measured Using EEG

    Baseline, Weeks 1 and 6

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: Standard Antipsychotic Therapy

RO4917838

EXPERIMENTAL
Drug: RO4917838Drug: Standard Antipsychotic Therapy

Interventions

PlaceboDRUG

Orally daily for 6 weeks

Placebo
RO4917838DRUG

10 mg daily orally for 6 weeks

RO4917838
Standard Antipsychotic TherapyDRUG

Participants will continue to receive their current antipsychotic treatment (as they are receiving at the time of screening). Protocol does not specify any particular standard antipsychotic therapy.

PlaceboRO4917838

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
  • Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
  • On stable treatment with a maximum of 2 antipsychotics

You may not qualify if:

  • Change in regimen for any psychotropic or sleep medication within 1 month
  • Treatment with more than (\>) 1 mood stabilizer or antidepressant
  • Use of clozapine within 2 months
  • Bipolar disorder, or more than mild anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

  • Kantrowitz JT, Epstein ML, Lee M, Lehrfeld N, Nolan KA, Shope C, Petkova E, Silipo G, Javitt DC. Improvement in mismatch negativity generation during d-serine treatment in schizophrenia: Correlation with symptoms. Schizophr Res. 2018 Jan;191:70-79. doi: 10.1016/j.schres.2017.02.027. Epub 2017 Mar 18.

    PMID: 28318835DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)