E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
THis research project will be performed with patients with a psychiatric disorder in order to determine whether the endocannabinoid system is altered in psychiatric diseases. Psychistric disorders that are investigated are schizophrenia, depression, ADHD, OCD and addiction. Patients will be compared with healthy controls. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10037175 |
E.1.2 | Term | Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051623 |
E.1.2 | Term | Cannabinoids |
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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 determine whether and how the endocannabinoid system is involved in psychiatric disorders. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Diagnosed with one psychiatric disorder (according to DSM-IV) •History of mild cannabis use for at least one year (<1/week and ≥ 4/year) •Right-handedness, assessed with the Edinburgh Handedness Inventory •Written informed consent of the patient
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E.4 | Principal exclusion criteria |
•Any clinical significant abnormality of any clinical laboratory test, except for the predetermined psychiatric disorder, including urinary drug screening •Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see paragraph 8.3.1) •Current diagnosis alcohol and/or drug abuse (DSM-IV criteria) •Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2 •Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug •The use of any medication within three weeks prior to the start of the study, except for paracetamol and medication for the psychiatric disorder •Claustrophobia •Metal objects in or around the body (braces, pacemaker, metal fragments)
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E.5 End points |
E.5.1 | Primary end point(s) |
THe investigator can decide to withdraw a patient from the study. This can be due to medical reasons, for example when serious side effects occur, or when patients need procedures that are not allowed in the protocol. In case of repeated withdrawal of patients for urgent medical reasons, the investigator will decide to end the study prematurely. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
involvement of endocannabinoid system in psychiatric disorders |
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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 | 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 | Yes |
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 | No |
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 | Yes |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |