CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 3 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.

Search/NCT01942733
NCT01942733Phase 3Completed
CompareCT.gov

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

H. Lundbeck A/S·interventional·Posted Sep 16, 2013·Updated Mar 20, 2019

In Brief

A Phase 3 clinical trial evaluating Brexpiprazole for Sleep Disturbances. Completed, enrolled 44 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disturbances
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 16, 2013
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.8 years ago

Interventions

Brexpiprazoledrug

2-3 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.