E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as ”the last visit of the last subject undergoing the study”. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |