Major Depressive Disorder
Conditions
Keywords
Depression, Depressive Disorder, MDD
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).
Interventions
DRUGAZD6765
IV once per dosing day, multiple times during the treatment period
DRUGPlacebo
0.9% saline IV once per dosing day multiple times during the treatment period
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed