A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00616798

Purpose

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, quetiapine, risperidone, paliperidone or aripiprazole) with prominent negative or disorganized thought symptoms. After a 4 week run in period on their current antipsychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Schizophrenia	Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters, C-SSRS [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Experimental	Drug: RO4917838 10mg po daily Drug: Standard antipsychotic therapy As prescribed
2: Experimental	Drug: RO4917838 30mg po daily Drug: Standard antipsychotic therapy As prescribed
3: Experimental	Drug: RO4917838 60mg po daily Drug: Standard antipsychotic therapy As prescribed
4: Placebo Comparator	Drug: Placebo po daily Drug: Standard antipsychotic therapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-60 years of age;
diagnosis of schizophrenia (based on screening tests);
outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
currently taking no more than 2 antipsychotic drugs.

Exclusion Criteria:

began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
on >1 antidepressant, or a change in dose of antidepressant within 3 months;
alcohol or substance abuse or dependence within 3 months;
has previously received RO4917838.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616798

Show 73 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NN20372
Study First Received:	February 4, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00616798 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009