At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 215 enrolled
Drug / intervention
MK-8435 (Org 25935) 4-8 mg +2 moredrug
Likely dose
MK-8435 (Org 25935) 4-8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Double-blind, Flexible-dose Efficacy Trial With Org 25935 Versus Placebo as add-on Therapy in Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia Treated With a Stable Dose of a Second Generation Antipsychotic (GIANT)
In Brief
A Phase 2 clinical trial evaluating MK-8435 (Org 25935) 4-8 mg, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 215 participants.
Detailed Summary
The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than placebo in improving negative symptoms in participants with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedJul 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJul 30, 2008
Enrollment StartApr 10, 2007
Primary CompletionOct 24, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.9 years ago
Interventions
MK-8435 (Org 25935) 4-8 mgdrug
Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day
Placebodrug
Matching placebo for MK-8435 (Org 25935) administered orally BID
MK-8435 (Org 25935) 12-16 mgdrug
Administered orally BID for a final concentration of 24-32 mg/day