At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Roflumilast +2 moredrug
Likely dose
Not stated in 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 Randomized, Double-Blind, Placebo Controlled, 3-period, Proof of Mechanism, Cross-Over Study of Roflumilast Administered up to Steady State to Evaluate the Effects of Add-on Roflumilast to Second Generation Antipsychotics on Cognitive Impairment as Well as Brain Imaging (ie, fMRI) and Electrical Activity (ie, EEG) Changes Observed in Subjects With Stable Schizophrenia
In Brief
A Phase 1 clinical trial evaluating Roflumilast, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether cognitive impairment associated with schizophrenia is attenuated by add-on roflumilast administration to second generation antipsychotics (SGA) in participants with stable schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedMar 2014
Primary CompletionJun 2015
TodayJul 2026
First PostedMar 6, 2014
Enrollment StartMar 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago
Interventions
Roflumilastdrug
Roflumilast tablets
Placebodrug
Roflumilast placebo-matching tablets
Second generation antipsychoticdrug
Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site.