CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,790 enrolled
Drug / intervention
Quetiapine 50 MG Extended Release Oral Tablet +2 moredrug
Likely dose
Quetiapine 50 MG Extended Release Oral Tabletfrom 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/NCT03207438
NCT03207438Phase 4Completed

Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression

University of Saskatchewan·interventional·Posted Jul 2, 2017·Updated Dec 4, 2019

In Brief

A Phase 4 clinical trial evaluating Quetiapine 50 MG Extended Release Oral Tablet, Quetiapine Fumarate XR 150-300 mg, and 1 other intervention for Depressive Disorder, Major. Completed, enrolled 1,790 participants.

Detailed Summary

In essence the researchers are hoping to test two separate hypotheses (described below in the form of research questions). Therefore, the proposed analysis has been outlined according to each hypothesis. Hypothesis 1: Is low-dose quetiapine (50 mg/day) more effective for patients with depression who have insomnia at treatment baseline? (Stated differently: is low-dose quetiapine 50 mg/day effective as monotherapy for patients with depression regardless of whether or not they have insomnia at baseline?). Hypothesis 2: Is high-dose quetiapine (150 - 300 mg/day) more effective for patients presenting with melancholic depression at treatment baseline?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2017
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2007
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9 years ago

Interventions

Quetiapine 50 MG Extended Release Oral Tabletdrug

OD

Quetiapine Fumarate XR 150-300 mgdrug

Dose ranged from 150 to 300mg, XR preparation, OD

Placebosdrug

Placebo