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

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• MDD with a HAM-D score of > 21 and > 1 on Item 1

Exclusion Criteria:

• Axis I disorder in last 6 months

• Axis II disorder causing significant impact

• Current depressive episode > 12 months or < 4 weeks

• No response of current episode to > 6 weeks treatment with 2 or more classes of antidepressant medication

• Substance abuse or dependence in last 6 months

• Significant medical illness

• Conditions that may alter study drug metabolism

• Significant suicide or homicide risk

• HAM-D Item 3 score > 2

• Suicide attempt in the last 6 months

• Lab or physical exam abnormalities

• CYP34A inhibitors in last 2 weeks

• Active psychotherapy (not supportive) unless ongoing for > 3 months

• Antipsychotic, antidepressant, or mood stabilizer in last 7 days (28 days for fluoxetine), MAOI or anxiolytic in last 14 days, or deport antipsychotic within 2 dosing intervals.