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
Overview
- Phase
- Phase 2
- Intervention
- AZD7268
- Conditions
- Major Depressive Disorder
- Sponsor
- AstraZeneca
- Enrollment
- 247
- Locations
- 1
- Primary Endpoint
- Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Arms & Interventions
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.
Intervention: AZD7268
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.
Intervention: Placebo tablets
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.
Intervention: Placebo capsules
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.
Intervention: Placebo tablets
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.
Intervention: Escitalopram
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.
Intervention: Placebo capsules
Outcomes
Primary Outcomes
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
Time Frame: Baseline, Week 4
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 Outcomes
- Montgomery-Åsberg Depression Rating Scale (MADRS) Response(Week 4)
- Montgomery-Åsberg Depression Rating Scale (MADRS) Remission(Week 4)
- Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.(Baseline, Week 4)
- Clinical Global Impression - Severity (CGI-S) Score Change From Baseline(Baseline, Week 4)
- Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline(Baseline, Week 4)