MedTrace Logo

Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia

NCT03075657 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-05-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Risperidone

Risperidone will be prescribed at dose of 2 mg per day

DRUG

Risperidone and Ramelteon

Ramelteon will be prescribed 8mg/day as an add-on therapy to Risperidone 2 mg per day

DRUG

Haloperidol

Haloperidol will be prescribed at a dose of 4 mg per day

DRUG

Haloperidol and Ramelteon

Ramelteon will be prescribed 8mg/day as an add-on therapy to Haloperidol 4 mg per day

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • DEBASISH HOTA, DM · AIIMS, BHUBANESWAR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-06-15
Completion
2018-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075657 on ClinicalTrials.gov