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

NCT03207438 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1790

Last updated 2019-12-04

Study results available
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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?

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Quetiapine 50 MG Extended Release Oral Tablet

OD

DRUG

Quetiapine Fumarate XR 150-300 mg

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

DRUG

Placebos

Placebo

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Rudy Bowen, MD, FRCPC · University of Saskatchewan

  • Lloyd Balbuena, PhD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-07-31
Completion
2019-10-31
FDA Drug
Yes

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Entities

Companies

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 NCT03207438 on ClinicalTrials.gov