At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
Risperidone +3 moredrug
Likely dose
Risperidone 2 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.
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Mar 9, 2017·Updated May 3, 2019
In Brief
A Phase 4 clinical trial evaluating Risperidone, Risperidone and Ramelteon, and 2 other interventions for Schizophrenia. Completed, enrolled 120 participants across 1 site.
Detailed Summary
The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMay 2017
Primary CompletionJun 2018
Study CompletionAug 2018
TodayJul 2026
First PostedMar 9, 2017
Enrollment StartMay 1, 2017
Primary CompletionJun 15, 2018
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago
Interventions
Risperidonedrug
Risperidone will be prescribed at dose of 2 mg per day
Risperidone and Ramelteondrug
Ramelteon will be prescribed 8mg/day as an add-on therapy to Risperidone 2 mg per day
Haloperidoldrug
Haloperidol will be prescribed at a dose of 4 mg per day
Haloperidol and Ramelteondrug
Ramelteon will be prescribed 8mg/day as an add-on therapy to Haloperidol 4 mg per day