AZD6765 Severe Major Depressive Disorder (MDD) IV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00781742
First received: October 27, 2008
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Drug: AZD6765
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 mg iv once per dosing day
Drug: AZD6765
IV once per dosing day, multiple times during the treatment period
Experimental: 2
150 mg iv once per dosing day
Drug: AZD6765
IV once per dosing day, multiple times during the treatment period
Placebo Comparator: 3 Drug: Placebo
0.9% saline IV once per dosing day multiple times during the treatment period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781742

  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Michael Castiglione AstraZeneca
Principal Investigator: Gerard Sanacora Yale University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00781742     History of Changes
Other Study ID Numbers: D6702C00009
Study First Received: October 27, 2008
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Depression
Depressive Disorder
MDD

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014