A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
Status:
Completed
Trial end date:
2014-05-26
Target enrollment:
Participant gender:
Summary
This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will
evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant
negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics,
will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks
(treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional
treatment extension for up to 3 years. After 52 weeks, participants who were originally
randomized to an active treatment will be randomly assigned to receive either placebo or
continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to
Week 56) for the assessment of potential withdrawal effects in a blinded manner using
participants staying on active treatment as a control. Participants initially randomized to
placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in
the washout period will return to their blinded, active treatment arm.