Schizophrenia | A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone

Schizophrenia research study

What is the primary objective of this study?

This randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to psychiatrically stable patients with schizophrenia receiving risperidone.

Who is eligible to participate?

Inclusion Criteria: - Males or females aged >/= 18 years and </= 60 years - Clinically stable, mild or moderate schizophrenia - On stable antipsychotic treatment for the last 6 months - Generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests - Willingness to be hospitalized for approximately 3 weeks - BMI > 18.5 kg/m2 and < 38 kg/m2 - Use of highly effective contraception as defined by the study protocol. Men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding Exclusion Criteria: - Treatment with antiparkinson medication including anticholinergic drugs - Treatment with depot antipsychotic medication within the last three months prior to screening - Participation in a clinical trial with an investigational drug or device < 3 months prior to screening - Smokes more than 20 cigarettes per day - Current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit - Any donation of blood or significant blood loss within three months prior to first administration of the study drug - Use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?


Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:PlaceboOral daily administration from Days 1-12

Drug:RO5545965Oral daily administration from Days 1-12

Drug:risperidone13 day run-in phase until 4 mg daily dose level is reached. 4 mg daily oral dose until Day 17 of study, for a total of 30 days. Dose may be increased up to 6 mg at the investigator's discretion. After study treatment, risperidone dosage may be decreased, increased or omitted at the investigator's discretion during a wash-out phase while patients return to their chronic antipsychotic treatment. Patient response during wash-out will be monitored in-house for 48 hours after the last dose of RO5545965 or placebo is administered. This in-house observation may be extended as needed by the investigator.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebo + risperidone

RO5545965 + risperidone

Study Status


Start Date: January 2014

Completed Date: August 2014

Phase: Phase 1

Type: Interventional


Primary Outcome: Incidence of adverse events

Secondary Outcome: Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965

Study sponsors, principal investigator, and references

Principal Investigator: Clinical Trials

Lead Sponsor: Hoffmann-La Roche


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