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Trials / Completed

CompletedNCT01942733

Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder

Interventional, Open-label, Flexible-dose, Exploratory Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
44 (actual)
Sponsor
H. Lundbeck A/S · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.

Conditions

Interventions

TypeNameDescription
DRUGBrexpiprazole2-3 mg/day, once daily, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgment.

Timeline

Start date
2013-09-01
Primary completion
2014-08-01
Completion
2014-08-01
First posted
2013-09-16
Last updated
2019-03-20
Results posted
2016-03-01

Source: ClinicalTrials.gov record NCT01942733. Inclusion in this directory is not an endorsement.

Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder (NCT01942733) · Clinical Trials Directory