AZD6765 Severe Major Depressive Disorder (MDD) IV

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00781742

Collaborator

(none)

152

Enrollment

Locations

Arms

Duration (Months)

5.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: AZD6765 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [Baseline to week 3]

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. [3 weeks]
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. [baseline to Day 1]
• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	Little Rock	Arkansas	United States
2	Research Site	Los Angeles	California	United States
3	Research Site	Orange	California	United States
4	Research Site	San Diego	California	United States
5	Research Site	Santa Ana	California	United States
6	Research Site	Hartford	Connecticut	United States
7	Research Site	New Haven	Connecticut	United States
8	Research Site	Boca Raton	Florida	United States
9	Research Site	Gainsville	Florida	United States
10	Research Site	Hollywood	Florida	United States
11	Research Site	Jacksonville	Florida	United States
12	Research Site	Atlanta	Georgia	United States
13	Research Site	Roswell	Georgia	United States
14	Research Site	Hoffman Estates	Illinois	United States
15	Research Site	Joliet	Illinois	United States
16	Research Site	Overland Park	Kansas	United States
17	Research Site	Lake Charles	Louisiana	United States
18	Research Site	Shreveport	Louisiana	United States
19	Research Site	Haverhill	Massachusetts	United States
20	Research Site	St. Louis	Missouri	United States
21	Research Site	Willingboro	New Jersey	United States
22	Research Site	Albuquerque	New Mexico	United States
23	Research Site	Rochester	New York	United States
24	Research Site	East Stroudsburg	Pennsylvania	United States
25	Research Site	Philadelphia	Pennsylvania	United States
26	Research Site	Austin	Texas	United States
27	Research Site	Dallas	Texas	United States