NCT03207438

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,790

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

June 29, 2017

Results QC Date

October 26, 2019

Last Update Submit

November 14, 2019

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (4)

  • 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)

    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).

    1 - 6 weeks

  • Modified MADRS Response Rates

    50% score reduction from baseline calculated without Item 4 (reduced sleep).

    1 - 6 weeks

  • MADRS Response Rates

    Defined as a 50% score reduction from baseline.

    Day 4 - Week 6

  • Modified MADRS Response Rate

    Calculated without Item 4 (reduced sleep).

    Day 4 - Week 6

Study Arms (4)

Quetiapine XR 50mg

EXPERIMENTAL

Quetiapine XR 50mg OD for 6 weeks

Drug: Quetiapine 50 MG Extended Release Oral Tablet

Placebo 1

PLACEBO COMPARATOR

Placebo OD for 6 weeks

Drug: Placebos

Quetiapine XR 150-300mg

EXPERIMENTAL

Quetiapine XR 150-300mg OD for 6 weeks

Drug: Quetiapine Fumarate XR 150-300 mg

Placebo 2

PLACEBO COMPARATOR

Placebo OD for 6 weeks

Drug: Placebos

Interventions

Quetiapine 50 MG Extended Release Oral TabletDRUG

OD

Quetiapine XR 50mg
Quetiapine Fumarate XR 150-300 mgDRUG

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

Quetiapine XR 150-300mg
PlacebosDRUG

Placebo

Placebo 1Placebo 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Trivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14.

    PMID: 23673347BACKGROUND

  • Weisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39. doi: 10.1097/YIC.0b013e32834d6f91.

    PMID: 22027845BACKGROUND

  • Weisler R, Joyce M, McGill L, Lazarus A, Szamosi J, Eriksson H; Moonstone Study Group. Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. CNS Spectr. 2009 Jun;14(6):299-313. doi: 10.1017/s1092852900020307.

    PMID: 19668121BACKGROUND

  • Agargun MY, Kara H, Solmaz M. Sleep disturbances and suicidal behavior in patients with major depression. J Clin Psychiatry. 1997 Jun;58(6):249-51. doi: 10.4088/jcp.v58n0602.

    PMID: 9228889BACKGROUND

  • Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Astrom M, Brecher M. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study. J Clin Psychiatry. 2009 Apr;70(4):526-39. doi: 10.4088/jcp.08m04592. Epub 2009 Apr 7.

    PMID: 19358790BACKGROUND

  • Bortnick B, El-Khalili N, Banov M, Adson D, Datto C, Raines S, Earley W, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: a placebo-controlled, randomized study. J Affect Disord. 2011 Jan;128(1-2):83-94. doi: 10.1016/j.jad.2010.06.031. Epub 2010 Aug 6.

    PMID: 20691481BACKGROUND

  • Wang G, McIntyre A, Earley WR, Raines SR, Eriksson H. A randomized, double-blind study of the efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder. Neuropsychiatr Dis Treat. 2014 Jan 30;10:201-16. doi: 10.2147/NDT.S50248. eCollection 2014.

    PMID: 24511235BACKGROUND

  • Mallinckrodt CH, Watkin JG, Liu C, Wohlreich MM, Raskin J. Duloxetine in the treatment of Major Depressive Disorder: a comparison of efficacy in patients with and without melancholic features. BMC Psychiatry. 2005 Jan 4;5:1. doi: 10.1186/1471-244X-5-1.

    PMID: 15631624BACKGROUND

  • McGrath PJ, Khan AY, Trivedi MH, Stewart JW, Morris DW, Wisniewski SR, Miyahara S, Nierenberg AA, Fava M, Rush AJ. Response to a selective serotonin reuptake inhibitor (citalopram) in major depressive disorder with melancholic features: a STAR*D report. J Clin Psychiatry. 2008 Dec;69(12):1847-55. doi: 10.4088/jcp.v69n1201. Epub 2008 Nov 18.

    PMID: 19026268BACKGROUND

  • Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, Peters TJ. Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol. 2004 Mar;57(3):229-36. doi: 10.1016/j.jclinepi.2003.08.009.

    PMID: 15066682BACKGROUND

  • Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol. 2013 Dec 7;13:152. doi: 10.1186/1471-2288-13-152.

    PMID: 24314264BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Evyn Peters
Organization
University of Saskatchewan
evyn.peters@usask.ca
13068441312

Study Officials

  • Rudy Bowen, MD, FRCPC

    University of Saskatchewan

    STUDY DIRECTOR

  • Lloyd Balbuena, PhD

    University of Saskatchewan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

April 1, 2006

Primary Completion

July 1, 2007

Study Completion

October 1, 2019

Last Updated

December 4, 2019

Results First Posted

December 4, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share