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

Purpose

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	Intervention	Phase
Schizophrenia	Drug: RO4917838 Drug: Placebo Drug: Standard antipsychotic therapy	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

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 ]


Enrollment:	323
Study Start Date:	March 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

More Information

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received:	February 4, 2008
Last Updated:	June 23, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants	Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015