Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

NCT ID: NCT00351169

Last Updated: 2008-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-06-30

Brief Summary

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To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Major Depressive Disorder MDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine SR

Intervention Type DRUG

Escitalopram

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 to 65 years
* A documented diagnosis of major depressive disorder

Exclusion Criteria

* Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
* Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Willie Earley, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Penticton, British Columbia, Canada

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Sydney, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Oakville, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Gatineau, Quebec, Canada

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Montreal, Quebec, Canada

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Beijing, , China

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HA Erbing, , China

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Nanjing, , China

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Shanghai, , China

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Wuhan, , China

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Helsinki, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Johor Bahru, , Malaysia

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Perak, , Malaysia

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Petaling Jaya, , Malaysia

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Aguascalientes, , Mexico

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Distrito Federal, , Mexico

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Guadalajara, , Mexico

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Cebu City, , Philippines

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Davao City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Benoni, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Krugersdorp, , South Africa

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Seoul, , South Korea

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Langreo, , Spain

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Vigo, , Spain

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Zamora, , Spain

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Countries

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Canada China Finland Malaysia Mexico Philippines South Africa South Korea Spain

References

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McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.

Reference Type DERIVED
PMID: 26474010 (View on PubMed)

Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.

Reference Type DERIVED
PMID: 24816198 (View on PubMed)

Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.

Reference Type DERIVED
PMID: 24175720 (View on PubMed)

Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.

Reference Type DERIVED
PMID: 24067192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23673347 (View on PubMed)

Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.

Reference Type DERIVED
PMID: 23485955 (View on PubMed)

Other Identifiers

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AMBER

Identifier Type: -

Identifier Source: secondary_id

EUDRACT No: 2005-005052-40

Identifier Type: -

Identifier Source: secondary_id

D1448C00004

Identifier Type: -

Identifier Source: org_study_id