AZD7268 Safety and Tolerability Study - Full Text View

Purpose

The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: AZD7268 Drug: Escitalopram Drug: Placebo capsules Drug: Placebo tablets	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 II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]

Secondary Outcome Measures:

Montgomery-Åsberg Depression Rating Scale (MADRS) Response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4. [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Clinical Global Impression - Severity (CGI-S) Score Change From Baseline [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 ("Normal, not ill") to 7 ("Among the most extremely ill patients"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]

Enrollment:	247
Study Start Date:	November 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD7268 The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.	Drug: AZD7268 15 mg, oral, twice daily (BID) Drug: Placebo tablets Placebo tablets to match encapsulated escitalopram
Placebo Comparator: Placebo The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.	Drug: Placebo capsules Placebo capsules to match AZD7268 Drug: Placebo tablets Placebo tablets to match encapsulated escitalopram
Active Comparator: Escitalopram The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.	Drug: Escitalopram 20 mg, oral, once daily (QD) Drug: Placebo capsules Placebo capsules to match AZD7268

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 prior to any study specific procedures
Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
296.2x Major Depressive Disorder, Single Episode, or
296.3x Major Depressive Disorder, Recurrent

Exclusion Criteria:

Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
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 started less than 4 weeks before enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020799

Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Florida
Research Site
Bradenton, Florida, United States
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, New York
Research Site
Cedarhurst, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
United States, Ohio
Research Site
Dayton, Ohio, 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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01020799 History of Changes
Other Study ID Numbers:	D1151C00005
Study First Received:	November 25, 2009
Results First Received:	January 11, 2012
Last Updated:	April 11, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by AstraZeneca:

Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 23, 2013