A clinical study with NEURAPAS® balance or a placebo drug, in addition to psychoeducation or psychotherapy in adolescents from 12 to 17 years suffering from mild depressive episodes with nervous restlessness

• Conditions: Mild depressive episodes with nervous restlessness; MedDRA version: 14.1Level: LLTClassification code 10012402Term: Depressive episodeSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2012-004627-20-DE
• Lead Sponsor: Pascoe pharmazeutische Präparate GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-21
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 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
owho are pregnant or lactating
owho 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified