Clinical trial NCT00616798: A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
timeFrame: Throughout study
measure: AEs, laboratory parameters, C-SSRS
timeFrame: Throughout study
Other outcomes:
Locations:
city: Granada Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Torrance
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Brooklyn
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: De Soto
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Wien
country: Austria
city: Wien
country: Austria
city: Curitiba
country: Brazil
city: Pelotas
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Marseille
country: France
city: Orvault
country: France
city: Toulon
country: France
city: Achim
country: Germany
city: Bochum
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Nürnberg
country: Germany
city: Westerstede
country: Germany
city: Balassagyarmat
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: GYR
country: Hungary
city: Gyula
country: Hungary
city: Nyíregyháza
country: Hungary
city: Aichi
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Gunma
country: Japan
city: Kanagawa
country: Japan
city: Kanagawa
country: Japan
city: Nagasaki
country: Japan
city: Saga
country: Japan
city: Sapporo
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Bydgoszcz
country: Poland
city: Kielce
country: Poland
city: Skorzewo
country: Poland
city: Torun
country: Poland
city: Tuszyn
country: Poland
city: Zuromin
country: Poland
city: Kazan
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: St Petersbourg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.