A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

Summary

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Timeline

Start

2011-01

Primary completion

2014-07

Completion

2014-07

Outcome

Missed primary endpoint

paper Results from the other two studies also did not differ from placebo PMID 27816567 ↗

paper TwiLyte 0·58, 95% CI -0·34 to 1·50, p=0·22 for 10 mg and 0·43, -0·49 to 1·36, p=0·36 PMID 27816567 ↗

Publications

• Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bitopertin	Small molecule	10 mg	Oral
Subject	bitopertin	Small molecule	20 mg	Oral

Indications