E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
F32.1 Moderate Depressive Episode |
|
MedDRA Classification |
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 assess the specific effect of an individualized homeopathic treatment with Q-potencies as compared to placebo for Major Depression (moderate depressive episode).
To assess the specific effect of a complete homeopathic patient history as compared to a rather conventional patient history.
|
|
E.2.2 | Secondary objectives of the trial |
Effect of homeopathic medicines after 2 and 4 weeks compared to placebo, and effect of a complete homeopathic patient history compared to a rather conventional patient history.
Safety evaluation
Effect of homeopathic medicines and placebo using patient history/case analysis Type 1 (complete homeopathic patient history plus homeopathic questionnaire) compared to the effect of homeopathic medicines and placebo using patient history/case analysis Type 2 (rather conventional patient history plus homeopathic questionnaire) (interaction)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients between 18 and 65 years
Major Depression diagnose made by a psychiatrist
Willingness to comply with study procedures
Patients not using antidepressants or anxiolytic drugs (exception Lorazepam, maximal dose 1.5 mg/day as rescue medication)
|
|
E.4 | Principal exclusion criteria |
mild depressive Episode: Hamilton Depression Score (HAM-D) < 17)
severe depressive Episode (HAM-D > 24)
Schizophrenia or other psychotic disorders, bipolar affective disorder, schizoaffective disorders, alcohol or other substance abuse, eating disorders
clinically significant Axis II disorder
presence of a clinically significant acute or chronic disease that would hinder the regular participation in the study
a severe depression that has led to a suicide attempt in patients' history.
suicidal ideation of type 4 oder 5 on the C-SSRS in the last month (i.e. active suicidal ideation with some intent to act, without specific plan; or active suicidal ideation with specific plan and intent)
suicide thoughts according to an analysis made from a Psychiatrist
treatment with antipsychotics, antidepressants or sedatives/hypnotics or mood stabilizers 4 weeks prior to study entry
complementary or alternative treatment during the study (for example, acupuncture, phytotherapy, etc.)
Homeopathic treatment 8 weeks prior study entry
Psychotherapy
patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical study and for not complying with the necessary study procedures
concomitant pregnancy or nursing
patients with pending pension application
persons who have been institutionalized by a court order |
|
E.5 End points |
E.5.1 | Primary end point(s) |
mean HAM-D total score after 6 weeks |
|
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 | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Different types of homeopathic case taking /analysis |
|
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 | 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.8.5 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |