A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

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ClinicalTrials.gov Identifier: NCT00616798

Recruitment Status : Completed

First Posted : February 15, 2008

Last Update Posted : June 24, 2014

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic 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 o n study treatment is <3 months, and the target sample size is 100-500 individual s.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	323 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	March 2008
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 3	Drug: RO4917838 60mg po daily Drug: Standard antipsychotic therapy As prescribed
Placebo Comparator: 4	Drug: Placebo po daily Drug: Standard antipsychotic therapy As prescribed
Experimental: 1	Drug: RO4917838 10mg po daily Drug: Standard antipsychotic therapy As prescribed
Experimental: 2	Drug: RO4917838 30mg po daily Drug: Standard antipsychotic therapy As prescribed

Outcome Measures

Primary Outcome Measures :

Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ]

Secondary Outcome Measures :

Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ]
AEs, laboratory parameters, C-SSRS [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616798

Show 73 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00616798 History of Changes
Other Study ID Numbers:	NN20372
First Posted:	February 15, 2008 Key Record Dates
Last Update Posted:	June 24, 2014
Last Verified:	June 2014

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antipsychotic Agents	Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs

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