Mild depressive episodes with nervous restlessness MedDRA version: 14.1 Level: LLT Classification code 10012402 Term: Depressive episode System Organ Class: 100000004873
Conditions
Interventions
Trade Name: NEURAPAS® balance
Pharmaceutical Form: Film-coated tablet
Other descriptive name: HYPERICI HERBAE EXTRACTUM SICCUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Pascoe pharmazeutische Präparate GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 12 and 17 years of age 2. Mild depressive episode, single or recurrent (according to ICD: F32.0 or F33.0); differential diagnosis (according to AWMF-guideline “Depressive Episoden und rezidivierende depressive Störungen (F32, F33), anhaltende affektive Störungen (F34)” and/or DGPPN guideline “Unipolare Depression” has ruled out other psychiatric conditions and somatic/organic cause of depressive episode 3. Diagnosis of the depressive episode between 2 weeks and 3 months prior to baseline 4. Presence of: depressed mood, loss of interest and enjoyment, increased fatigability 5. CDRS-R = 35 and = 45 6. CGI Item 1 (severity of illness) = “mildly ill” 7. Presence of nervous restlessness (patient is restless or agitated or stressed or feels driven and in addition is nervous since at least 2 weeks) 8. Concomitant psychoeducation or psychotherapy (e.g. but not limited to cognitive behavioral therapy or interpersonal therapy together with or without family therapy) 9. Based on the appraisal of the investigator: adequate educational as well as intelligence level and ability to communicate of patients, parents/legal guardians in order to fulfill the requirements of the trial 10. Written informed consent of the patients 11. Written informed consent of the parents/legal guardians 12. Negative pregnancy test at the baseline visit (prior to the first intake of study medication) for female patients. Are the trial subjects under 18? yes Number of subjects for this age range: 380 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1-11: Manic or bipolar disorders, Psychotic depression, Anorexia, Bulimia, Borderline personality disorders, Attention deficit disorder or hyperactivity disorder, Evidence for drug or alcohol abuse, Schizophrenia, Schizoaffective disorders, Psychosis, Deliria 12. Current suicidal ideation (item „suicidal ideation“ on the CDRS-R = 4, 5, 6 or 7 or any other indication for current suicidal ideation) 13. Organic brain disorders 14. Known photosensitivity of the skin 15. Patients who did not respond to any prior antidepressive drug treatment 16. Currently taking or past intake during the last 4 weeks prior to baseline or planned prescription during the trial of: psychotropic or centrally acting drugs (including herbal preparations and homeopathic preparations) including but not limited to antidepressants, lithium, psychostimulating agents, sedatives, hypnotics, tranquilizers 17. Concomitant treatment with or planned prescription during the trial of: tacrolimus for systemic use, sirolimus, ciclosporin, non-nucleoside-reverse-transcriptase-inhibitors such as nevirapine, protease-inhibitors, anticoagulants, cytostatic agents such as imatinib, irinotecan except for monoclonal antibodies, theophylline, digoxin, ivabradine, verapamil, simvastatin 18. Planned or foreseeable change of the concomitant psychoeducation or psychotherapy (e.g. but not limited to cognitive behavioral therapy or interpersonal therapy with or without family therapy) 19. Any other non-drug treatment of the depression or the nervous restlessness except for the established concomitant psychoeducation or psychotherapy 20. Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication 21. Patients who currently receive a drug during a clinical trial or who have received a drug during a clinical trial within the last 30 days prior to inclusion 22. Patients who are hospitalized or in psychiatric care due to court or other authority order 23. Female patients o who are pregnant or lactating o who menstruate and are capable of becoming pregnant and who practice sexual intercourse and do not use a medically accepted method of contraception (Pearl-index < 1) during the study treatment and at least 4 weeks thereafter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To compare each of the two NEURAPAS® balance dosages to placebo and both NEURAPAS® balance dosages among each other with respect to: o Improvement of depressive symptoms, measured by means of the German version of the CDRS-R (Children's Depression Rating Scale, Revised) after 6 weeks treatment • To compare pooled data of both NEURAPAS® balance dosages to placebo, each of the two NEURAPAS® balance dosages to placebo and both NEURAPAS® balance dosages among each other with respect to: o improvement of depressive symptoms, measured by means of the German version of the CDRS-R (Children's Depression Rating Scale, Revised) after 2 and 4 weeks treatment o status changes (global improvement), evaluated by means of the CGI item 2 after 2, 4 and 6 weeks of treatment o improvement of nervous restlessness, evaluated by means of a numerical rating scale with the values 0 to 10 after 2, 4 and 6 weeks treatment - tolerability and safety ;Main Objective: The main objective is to prove superiority of NEURAPAS® balance (pooled data of both dosages) compared to placebo in improving depressive symptoms, measured by means of the German version of the CDRS-R (Children's Depression Rating Scale, Revised) after 6 weeks treatment ;Primary end point(s): Primary efficacy endpoint: - Change from baseline of CDRS-R at week 6 ;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoint: • Responder rate: proportion of patients with a CDRS-R reduction from baseline by = 40% at week 6 Further secondary efficacy endpoints: • Change from baseline of CDRS-R at week 2 and week 4 • Proportion of patients with remission of depression (defined as CDRS-R = 28) at weeks 2, 4 and 6 • Proportion of patients with a CDRS-R reduction from baseline by = 10%, = 20%, = 30%, = 50% at week 6 • Change from baseline of CGI item 1 (severity of illness) at weeks 2, 4 and 6 • CGI item 2 (global improvement) at weeks 2, 4 and 6 • Proportion of patients with a CGI item 2 (global improvement) rating „very much improved“ or „much improved“ or „minimally improved“ at weeks 2, 4 and 6 • Change from baseline of nervous restlessness at weeks 2, 4 and 6 assessed by a numerical rating scale with the values 0 to 10 Safety and tolerability endpoints: • Incidence of adverse events (AE) and serious adverse events (SAE) • Cognition: change of d2-R at weeks 2, 4 and 6 • Change of vital signs (heart rate, blood pressure) • Change from baseline of weight and height • Change from baseline in safety laboratory parameters • Proportion of clinically relevant laboratory parameter changes • Clinically relevant findings in the physical examination ;Timepoint(s) of evaluation of this end point: week 2, 4 and 6; responder rate: week 6 | — |
Countries
Germany
Contacts
Public ContactProject manager
GKM Gesellschaft für Therapieforschung mbH
Outcome results
None listed