A phase I, multi-centre, double-blind, placebo-controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female patients fulfilling the criteria for Major Depressive Disorder
- Conditions
- Major Depressive DisorderMedDRA version: 12.0Level: LLTClassification code 10025453Term: Major depressive disorder NOS
- Registration Number
- EUCTR2009-013110-27-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method