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Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder (DIAMOND)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine fumarate
Duloxetine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Quetiapine fumarate, sustained release, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has a documented clinical diagnosis of Major Depressive Disorder. Be able to understand and comply with the requirements of the study. Able to understand and provide written informed consent Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).

Sites / Locations

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Outcomes

Primary Outcome Measures

Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Change from randomization to each assessment in the MADRS total score
MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

Full Information

First Posted
May 1, 2006
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00321490
Brief Title
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder
Acronym
DIAMOND
Official Title
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Quetiapine fumarate, sustained release, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Primary Outcome Measure Information:
Title
Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary Outcome Measure Information:
Title
Change from randomization to each assessment in the MADRS total score
Title
MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has a documented clinical diagnosis of Major Depressive Disorder. Be able to understand and comply with the requirements of the study. Able to understand and provide written informed consent Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Art Lazarus, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Sherman Oaks
State/Province
California
Country
United States
Facility Name
Research Site
City
Wildomar
State/Province
California
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Edwardsville
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Okemos
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
St. Paul
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Princeton
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
New York City
State/Province
New York
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Mayfield Village
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Salem
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26474010
Citation
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.
Results Reference
derived
PubMed Identifier
24816198
Citation
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.
Results Reference
derived
PubMed Identifier
24175720
Citation
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.
Results Reference
derived
PubMed Identifier
24067192
Citation
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.
Results Reference
derived
PubMed Identifier
23673347
Citation
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. Erratum In: Int J Neuropsychopharmacol. 2015;18(2). pii: pyu086. doi: 10.1093/ijnp/pyu086. Papakosts, George I [corrected to Papakostas, George I]. Int J Neuropsychopharmacol. 2015 Jul;18(9). pii: pyv056. doi: 10.1093/ijnp/pyv056.
Results Reference
derived
PubMed Identifier
23497790
Citation
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.
Results Reference
derived
PubMed Identifier
23485955
Citation
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.
Results Reference
derived
PubMed Identifier
22027845
Citation
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.
Results Reference
derived
PubMed Identifier
19358790
Citation
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. Erratum In: J Clin Psychiatry. 2009 Dec;70(12):1729.
Results Reference
derived

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Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

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