EUCTR2012-004627-20-DE
Active, not recruiting
Not Applicable
Randomized double-blind, placebo controlled study with NEURAPAS® balance in addition to psychoeducation or psychotherapy in adolescents from 12 to 17 years suffering from mild depressive episodes with nervous restlessness
ConditionsMild depressive episodes with nervous restlessnessMedDRA version: 14.1Level: LLTClassification code 10012402Term: Depressive episodeSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
DrugsNEURAPAS® balance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild depressive episodes with nervous restlessness
- Sponsor
- Pascoe pharmazeutische Präparate GmbH
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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