E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants. |
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E.2.2 | Secondary objectives of the trial |
To evaluate biomarkers such as cytokines, tryptophan metabolism and endocrine parameters pre and post ketamine treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Be able to give written informed consent,
•Be between the ages of 18 and 65 years of age, male or female
•DSM-IV major depression with a Hamilton depression score greater than 17
•Failed trial of an SSRI antidepressant at an adequate dose for at least 6 weeks duration
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E.4 | Principal exclusion criteria |
•Are less than 18 and greater than 65 years of age,
•Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal, immunological, or any condition which contraindicates, in the investigators judgement, entry to the study].
•Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include, anti-inflammatory medications to include aspirin and steroids.
•Have evidence of immunodeficiency; bleeding disorder or coagulopathy.
•Pregnancy
•Family or Personal history of psychosis |
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E.5 End points |
E.5.1 | Primary end point(s) |
When 20 patients with SSRI- (Antidepressant) resistant Depression have completed 3 sessions of weekly IV Ketamine and have been evaluated 2 weeks post-last ketamine infusion. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 weeks following last ketamine infusion for last of 20 patients |
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E.5.2 | Secondary end point(s) |
When biomarkers i.e. cytokines, tryptophan metabolism markers and endocrine parameters have been measured pre and post ketamine treatment for the 20 patients |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Use of anaesthetic ketamine for a different indication i.e. in depression in subanaesthetic doses |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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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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 | 1 |
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 |