Skip to main content
OpenTrials
Completed

NCT Number: NCT01020799

AZD7268 Safety and Tolerability Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD7268

Drug

15 mg, oral, twice daily (BID)

Escitalopram

Drug

20 mg, oral, once daily (QD)

placebo capsules

Drug

Placebo capsules to match AZD7268

Placebo tablets

Drug

Placebo tablets to match encapsulated escitalopram

Primary outcomes

  1. 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

  1. Montgomery-Åsberg Depression Rating Scale (MADRS) Response

    Time frame: Week 4

    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)]

  2. Montgomery-Åsberg Depression Rating Scale (MADRS) Remission

    Time frame: Week 4

    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)]

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

    Time frame: Baseline, 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)]

  4. Clinical Global Impression - Severity (CGI-S) Score Change From Baseline

    Time frame: Baseline, Week 4

    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)]

  5. Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline

    Time frame: Baseline, Week 4

    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)]

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2009
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.