A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

NCT ID: NCT01116830

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally daily for 6 weeks

Standard Antipsychotic Therapy

Intervention Type DRUG

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.

RO4917838

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

10 mg daily orally for 6 weeks

Standard Antipsychotic Therapy

Intervention Type DRUG

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.

Interventions

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Placebo

Orally daily for 6 weeks

Intervention Type DRUG

RO4917838

10 mg daily orally for 6 weeks

Intervention Type DRUG

Standard Antipsychotic Therapy

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Orangeburg, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28318835 (View on PubMed)

Other Identifiers

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BP22445

Identifier Type: -

Identifier Source: org_study_id