Phase 4 Completed N=1,790 Randomized Double-blind Treatment

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

Depressive Disorder, Major

Source: ClinicalTrials.gov NCT03207438 ↗

Enrolled (actual)

1,790

Serious AEs

—

Results posted

Dec 2019

Primary outcomePrimary: 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) — 63; 28; 86; 47 Participants — p=<.001

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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?

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	63; 28; 86; 47; 105; 41	<.001 sig
PRIMARY Modified MADRS Response Rates	53; 26; 68; 46; 90; 45	<.001 sig
PRIMARY MADRS Response Rates	8; 6; 0; 0; 26; 12	.33
PRIMARY Modified MADRS Response Rate	6; 6; 22; 11; 44; 28	.5

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03207438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.