NCT01145755

Brief Summary

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

13 active sites

Status
terminated

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

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 27, 2012

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

May 27, 2010

Results QC Date

August 28, 2012

Last Update Submit

September 27, 2012

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • MADRS Total Score Change From Baseline to Week 6

    Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

    6 weeks

Secondary Outcomes (2)

  • MADRS Response

    6 weeks

  • MADRS Remission

    6 weeks

Study Arms (3)

AZD2066

EXPERIMENTAL
Drug: AZD2066

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Duloxetine

ACTIVE COMPARATOR

Duloxetine

Drug: Duloxetine

Interventions

AZD2066DRUG

18 mg once daily

AZD2066
PlaceboDRUG
Placebo
DuloxetineDRUG

60 mg once daily

Duloxetine

Eligibility Criteria

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

You may qualify if:

  • Provision of signed, written, and dated Informed Consent
  • Documented primary clinical diagnosis of Major Depressive Disorder

You may not qualify if:

  • Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
  • Patients whose current episode of depression started less than 4 weeks before enrollment
  • History of inadequate response of antidepressants during current depressive episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Garden Grove, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

Jacksonville, Florida, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Rockville, Maryland, United States

Location

Research Site

Boston, Massachusetts, United States

Location

Research Site

Cedarhurst, New York, United States

Location

Research Site

Rochester, New York, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Memphis, Tennessee, United States

Location

Research Site

Friendswood, Texas, United States

Location

Research Site

Bellevue, Washington, United States

Location

Research Site

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

AZD2066Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
645895

Study Officials

  • Richard Malamut

    AstraZeneca

    STUDY CHAIR

  • Lora McGill

    CNS Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2010

First Posted

June 17, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 3, 2012

Results First Posted

September 27, 2012

Record last verified: 2012-09

Locations

US(13)