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

NCT03207438 Phase 4 COMPLETED Results posted

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?

Details

Lead sponsor	University of Saskatchewan
Phase	Phase 4
Status	COMPLETED
Enrolment	1790
Start date	2006-04
Completion	2019-10

Conditions

• Depressive Disorder, Major

Interventions

• Quetiapine 50 MG Extended Release Oral Tablet
• Quetiapine Fumarate XR 150-300 mg
• Placebos

Primary outcomes

• Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic) — 1 - 6 weeks
  MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response).
• Modified MADRS Response Rates — 1 - 6 weeks
  50% score reduction from baseline calculated without Item 4 (reduced sleep).
• MADRS Response Rates — Day 4 - Week 6
  Defined as a 50% score reduction from baseline.
• Modified MADRS Response Rate — Day 4 - Week 6
  Calculated without Item 4 (reduced sleep).