AZD7268 Safety and Tolerability Study

Phase 2CompletedNCT01020799

AstraZeneca247 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

247

Conditions

Major Depressive Disorder

Interventions

AZD7268DRUG

15 mg, oral, twice daily (BID)

EscitalopramDRUG

20 mg, oral, once daily (QD)

Placebo capsulesDRUG

Placebo capsules to match AZD7268

Placebo tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (17)

Research Site

Birmingham, Alabama, United States

Research Site

Garden Grove, California, United States

Research Site

San Diego, California, United States

Outcomes

Primary Outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to 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. \[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\]

Time frame: Baseline, Week 4

Secondary Outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS) Response

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). \[Full Analysis Set (FAS)\]

Time frame: Week 4

Montgomery-Åsberg Depression Rating Scale (MADRS) Remission

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). \[Full Analysis Set (FAS)\]

Time frame: Week 4

Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.

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. \[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\]

Data from ClinicalTrials.gov

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