6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
This study has been terminated.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145755
First received: May 27, 2010
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: AZD2066 Drug: Placebo Drug: Duloxetine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- MADRS Total Score Change From Baseline to Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- MADRS Response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
- MADRS Remission [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
| Enrollment: | 131 |
| Study Start Date: | May 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD2066 |
Drug: AZD2066
18 mg once daily
|
| Placebo Comparator: Placebo | Drug: Placebo |
|
Active Comparator: Duloxetine
Duloxetine
|
Drug: Duloxetine
60 mg once daily
|
Detailed Description:
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of signed, written, and dated Informed Consent
- Documented primary clinical diagnosis of Major Depressive Disorder
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145755
Locations
| United States, California | |
| Research Site | |
| Garden Grove, California, United States | |
| Research Site | |
| San Diego, California, United States | |
| United States, Florida | |
| Research Site | |
| Jacksonville, Florida, United States | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States | |
| United States, Maryland | |
| Research Site | |
| Rockville, Maryland, United States | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| Research Site | |
| Cedarhurst, New York, United States | |
| Research Site | |
| Rochester, New York, United States | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, Tennessee | |
| Research Site | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Research Site | |
| Friendswood, Texas, United States | |
| United States, Washington | |
| Research Site | |
| Bellevue, Washington, United States | |
| Research Site | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Chair: | Richard Malamut | AstraZeneca |
| Principal Investigator: | Lora McGill | CNS Healthcare |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01145755 History of Changes |
| Other Study ID Numbers: | D0475C00020 |
| Study First Received: | May 27, 2010 |
| Results First Received: | August 28, 2012 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Depression |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013