Major Depressive Disorder MedDRA version: 12.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Product Name: AZD6765
Product Code: AZD6765
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo:
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male subjects aged 18-45 years, inclusive at enrolment. 2. Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the Investigator) use of a highly effective form of birth control. 3. Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview (SCID) for any of the following 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent 4. Outpatient status at screening and randomisation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a DSM IV Axis II disorder which has a major impact on the subjects current psychiatric status. 2. Subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression. 3. Subjects’ use of mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs within 14 days of Visit 2. 4. Subjects with a positive urine toxicology at screening (UTS) or at Visit 2 for cocaine and/or metabolites, amphetamines, opiates, phencyclidine (PCP), and barbiturates will be excluded except for subjects testing positive for prescribed medications. Subjects can be re-tested if the UTS is positive, but should be excluded if the results are still positive. 5. OTC medicine within 48 hours prior to Visit 2. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety. 6. Use of any medications that could confound MRI signal per judgement of Investigator. 7. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to assess the effect of a single dose iv infusion of ketamine (Part 1) and AZD6765 (Part 2) compared to placebo on the Blood Oxygen Level Dependent (BOLD) signal in brain area BA25 using functional Magnetic Resonance Imaging (fMRI) in subjects meeting the criteria for Major Depressive Disorder (MDD).;Secondary Objective: To assess whether a single dose iv infusion of ketamine (Part 1) and AZD6765 (Part 2) alter the effects of emotional processing on the BOLD signal in various brain areas such as BA25, amygdala and other areas of interest. ;Primary end point(s): The primary objective for this study is to assess the effect of a single dose iv infusion of ketamine (Part 1) and AZD6765 (Part 2) compared to placebo on the Blood Oxygen Level Dependent (BOLD) signal in brain area BA25 using functional Magnetic Resonance Imaging (fMRI) in subjects meeting the criteria for Major Depressive Disorder (MDD). | — |
Countries
United Kingdom
Outcome results
None listed