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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207438
Recruitment Status : Completed
First Posted : July 2, 2017
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Evyn Peters, University of Saskatchewan

Brief 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?


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Quetiapine 50 MG Extended Release Oral Tablet Drug: Quetiapine Fumarate XR 150-300 mg Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression
Actual Study Start Date : April 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: Quetiapine XR 50mg
Quetiapine XR 50mg OD for 6 weeks
Drug: Quetiapine 50 MG Extended Release Oral Tablet
OD

Placebo Comparator: Placebo 1
Placebo OD for 6 weeks
Drug: Placebos
Placebo

Experimental: Quetiapine XR 150-300mg
Quetiapine XR 150-300mg OD for 6 weeks
Drug: Quetiapine Fumarate XR 150-300 mg
Dose ranged from 150 to 300mg, XR preparation, OD

Placebo Comparator: Placebo 2
Placebo OD for 6 weeks
Drug: Placebos
Placebo




Primary Outcome Measures :
  1. 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) [ Time Frame: 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).

  2. Modified MADRS Response Rates [ Time Frame: 1 - 6 weeks ]
    50% score reduction from baseline calculated without Item 4 (reduced sleep).

  3. MADRS Response Rates [ Time Frame: Day 4 - Week 6 ]
    Defined as a 50% score reduction from baseline.

  4. Modified MADRS Response Rate [ Time Frame: Day 4 - Week 6 ]
    Calculated without Item 4 (reduced sleep).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207438


Sponsors and Collaborators
University of Saskatchewan
AstraZeneca
Investigators
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Study Director: Rudy Bowen, MD, FRCPC University of Saskatchewan
Study Director: Lloyd Balbuena, PhD University of Saskatchewan
Additional Information:
Publications:

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Responsible Party: Evyn Peters, Resident Physician, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03207438    
Other Study ID Numbers: D1448C0001 (through ...0004)
First Posted: July 2, 2017    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs