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Completed

NCT Number: NCT00781742

AZD6765 Severe Major Depressive Disorder (MDD) IV

The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).

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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, Little Rock, Arkansas, 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

  • Signed informed consent before any study-related procedures start.
  • The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
  • Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.

Exclusion criteria

  • Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
  • Patient has a lifetime history of failure to ECT therapy.
  • Patient is pregnant or breast feeding.
  • Length of current episode of depression exceeds ≥2 years.

Treatment and study plan

AZD6765

Drug

IV once per dosing day, multiple times during the treatment period

Placebo

Drug

0.9% saline IV once per dosing day multiple times during the treatment period

Primary outcomes

  1. To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score

    Time frame: Baseline to week 3

Secondary outcomes

  1. To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.

    Time frame: 3 weeks

  2. To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.

    Time frame: baseline to Day 1

  3. • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2008
Registry last updated
Jul 25, 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.

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