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

NCT ID: NCT00351910

Last Updated: 2011-01-26

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

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-04-30

Brief Summary

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To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with 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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Quetiapine

Intervention Type DRUG

Amitriptyline

Intervention Type DRUG

Bupropion

Intervention Type DRUG

Citalopram

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

Escitalopram

Intervention Type DRUG

Fluoxetine

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

Sertraline

Intervention Type DRUG

Venlafaxine

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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Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Everton Park, Queensland, Australia

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Southport, Queensland, Australia

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Frankston, Victoria, Australia

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Malvern, Victoria, Australia

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Prahran, Victoria, Australia

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Richmond, Victoria, Australia

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Brisbane, , Australia

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Assebroek, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Liège, , Belgium

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Mechelen, , Belgium

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Tielt, , Belgium

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Edmonton, Alberta, Canada

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Moncton, New Brunswick, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Brno, , Czechia

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Havířov, , Czechia

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Havlíčkův Brod, , Czechia

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Nové Město nad Metují, , Czechia

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Olomouc, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Helsinki, , Finland

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Järvenpää, , Finland

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Salo, , Finland

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Turku, , Finland

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Angoulême, , France

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Arcachon, , France

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Caen, , France

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Château-Gontier, , France

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Élancourt, , France

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Le Pecq, , France

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Nîmes, , France

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Paris, , France

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Rennes, , France

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Toulouse, , France

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Augsburg, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Münster, , Germany

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Bergen, , Norway

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Flekkefjord, , Norway

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Fyllingsdalen, , Norway

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Hamar, , Norway

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Lysaker, , Norway

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Oslo, , Norway

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Skien, , Norway

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Gdansk, , Poland

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Lodz, , Poland

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Nowy Targ, , Poland

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Szczecin, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Bucharest, , Romania

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Piteşti, , Romania

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Falköping, , Sweden

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Gothenburg, , Sweden

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Halmstad, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Trollhättan, , Sweden

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Uppsala, , Sweden

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Countries

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Australia Belgium Canada Czechia Finland France Germany Norway Poland Romania South Africa Sweden

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, Bauer M. Extended-release quetiapine fumarate in the treatment of patients with major depressive disorder: adjunct therapy. Expert Rev Neurother. 2013 Nov;13(11):1183-200. doi: 10.1586/14737175.2013.846519.

Reference Type DERIVED
PMID: 24175721 (View on PubMed)

Bauer M, Demyttenaere K, El-Khalili N, Thase ME, Papakostas GI, Szamosi J, Earley WR, Eriksson H. Pooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment. Int Clin Psychopharmacol. 2014 Jan;29(1):16-25. doi: 10.1097/YIC.0000000000000011.

Reference Type DERIVED
PMID: 24108148 (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)

Bauer M, McIntyre RS, Szamosi J, Eriksson H. Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy. Int J Neuropsychopharmacol. 2013 Sep;16(8):1755-65. doi: 10.1017/S146114571300031X. Epub 2013 May 14.

Reference Type DERIVED
PMID: 23672772 (View on PubMed)

Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.

Reference Type DERIVED
PMID: 23497790 (View on PubMed)

Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. doi: 10.4088/jcp.08m04629. Epub 2009 Apr 7.

Reference Type DERIVED
PMID: 19358791 (View on PubMed)

Other Identifiers

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ONYX

Identifier Type: -

Identifier Source: secondary_id

EUDRACT No: 2005-0055053-22

Identifier Type: -

Identifier Source: secondary_id

D1448C00007

Identifier Type: -

Identifier Source: org_study_id

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