E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10057840 |
E.1.2 | Term | Major depression |
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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 of this trial is to investigate short-term antidepressant effects of an adjuvant standard occupational therapy group program in comparison with a non-therapeutic play group condition in in-patients with major depression, concurrently being treated with mirtazapine. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are: · to assess and to compare antidepressive response within both groups at weeks 3 and 6 as measured by a HamD score reduction of ≥ 50 %; · to quantify effects of add-on occupational therapy on the levels of psycho-social functioning and abilities as well as coping with demands of daily living, and to check the relationship between these measures and the primary outcome parameter; · to measure effects of add-on occupational therapy on psychomotor functioning and coordination (kinematic analysis of handwriting movements); · to measure patients’ satisfaction with the occupational program, compared with the play group condition; · to generate hypotheses on the cost-benefit ratio of standard occupational therapy; · and, to study gender differences concerning all treatment outcome parameters. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· male and female inpatients, 18 to 65 years of age · patients must have a diagnosis of moderate or severe major depression without psychotic or catatonic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV: 296.22, 296.23, 296.32, 296.33), and confirmed by the Structured Clinical Interview for DSM (SCID-I) · Hamilton Depression Rating Scale (HamD-17) score ≥ 18 · female patients must test negative for pregnancy and, if of childbearing potential, must be using a highly effective method of birth control (Pearl Index < 1%) before entry and throughout the study. Effective methods of birth control include oral hormonal contraceptives, contraceptive injections, contraceptive patch and male partner sterilization. · patients in whom a minimum in-patient hospitalisation stay of at least 7 weeks (when enrolled in the study) is acceptable, in the clinical judgement of the investigator · patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol · patients must be able to understand the nature of the study and have given their own informed consent |
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E.4 | Principal exclusion criteria |
· patients in whom treatment with mirtazapine is relatively or absolutely clinically contraindicated · patients who have received an experimental drug or used an experimental medical device for any indication within 30 days prior to Visit 1 · patients who have a history of inadequate response to an adequate treatment with mirtazapine, in the opinion of the investigator · patients who require concomitant treatment with any other medication with primary central nervous system activity, other than benzodiazepines · patients at risk of suicide (e.g. history of any suicide attempts, any current suicidal intent including plan) · DSM-IV diagnosis of dementia, schizophrenia spectrum disorder, bipolar affective disorder, cluster A or cluster B personality disorder, substance use disorder (abuse and dependence), and some forms of anxiety disorders (acute panic disorder, acute agoraphobia, acute social phobia, and acute general anxiety disorder), eating disorders (anorexia and bulimia nervosa) · history of convulsion or seizure disorder · severe physical disabilities · female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study · aminotransferase levels > 2 times upper limit of normal (ULN) at Visit 1 · thyroid-stimulating hormone (TSH) > 10% above the ULN at Visit 1 · clinically significant ECG abnormalities at Visit 1 · patients with acute, serious, or unstable medical conditions · employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator |
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E.5 End points |
E.5.1 | Primary end point(s) |
· changes in the Hamilton Depression Rating Scale (HamD) from baseline to endpoint (Day 42) and from baseline to interim weekly visits (Day 1 to 21) · improvement of psychosocial functioning and abilities as well as coping with demands of daily living · improvement of psychomotor functioning and coordination |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Efficacy of adjuvant standard occupational therapy |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Non-therapeutic play group condition |
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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 | 4 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |