At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 91 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 0.5mgfrom 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.
Varenicline Adjunctive Treatment in Schizophrenia
In Brief
A Phase 4 clinical trial evaluating Varenicline and Placebo for Schizophrenia and 2 related conditions. Completed, enrolled 91 participants across 3 sites.
Detailed Summary
The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsStanley Medical Research Institute
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedJun 2007
Primary CompletionMay 2010
Study CompletionApr 2011
TodayJul 2026
First PostedJun 27, 2007
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.0 years ago
Interventions
Vareniclinedrug
Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Placebodrug
Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks