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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616798
First Posted: February 15, 2008
Last Update Posted: June 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
February 4, 2008
February 15, 2008
June 24, 2014
March 2008
February 2010   (Final data collection date for primary outcome measure)
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ]
Same as current
Complete list of historical versions of study NCT00616798 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]
Not Provided
Not Provided
 
A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: RO4917838
    10mg po daily
  • Drug: RO4917838
    30mg po daily
  • Drug: RO4917838
    60mg po daily
  • Drug: Placebo
    po daily
  • Drug: Standard antipsychotic therapy
    As prescribed
  • Experimental: 3
    Interventions:
    • Drug: RO4917838
    • Drug: Standard antipsychotic therapy
  • Placebo Comparator: 4
    Interventions:
    • Drug: Placebo
    • Drug: Standard antipsychotic therapy
  • Experimental: 1
    Interventions:
    • Drug: RO4917838
    • Drug: Standard antipsychotic therapy
  • Experimental: 2
    Interventions:
    • Drug: RO4917838
    • Drug: Standard antipsychotic therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
February 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Brazil,   France,   Germany,   Hungary,   Japan,   Mexico,   Poland,   Russian Federation,   United States
Romania
 
NCT00616798
NN20372
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP