Clinical trial to evaluate the relapse prevention of a hypericum extract in patients with major depressio
- Conditions
- Moderate depressive episodesTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2008-001417-26-DE
- Lead Sponsor
- Steigerwald Arzneimittelwerk GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Phase 1: age 18-70 years, diagnosis according to DSM-IV-TR: 296.32; total score of HAMD-17 20-24 points. At least 5 of the listed symptoms are to exist for 2 weeks (at least 1 of them = main symptom, like depressive mood or loss of interest and joy).
Phase 2: Responder of phase 1 (= decrease of HAMD-17 total score of at least 50% after a 12-week treatment with Laif 900).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Phase 1 and 2: incapable of contructing and attanded patients according to the Betreuungsgesetz (BtG); simple mourning reaction; drugs that may influence the efficacy of or could be influenced by the investigational product; pregnancy and nursing; cancer or AIDS (HIV positive)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase 1: Non, this phase is used for achieving responder for phase 2.<br>Phase 2: Comparison of the relapse rates in both groups at the end of phase 2, measured by the total score of HAMD-17 (Relaps = Increase > or = 5 points according to baseline in phase 2).;Secondary Objective: Hamilton Depression Scale (HAMD-17): Course (phase 2); time between baseline and occurrence of relaps (phase 2)<br>Beck Depression Inventory (BDI) (phase 2)<br>Clinical Global Impressions (CGI) (phase 2);Primary end point(s): Phase 1: Non, serves only to achieve responder for phase 2.<br>Phase 2: Comparison of the relapse rates in both groups at the end of phase 2, measured by the total score of HAMD-17 (relaps = Increase > or = 5 points compared to baseline in phase 2).;Timepoint(s) of evaluation of this end point: 0, 4, 8, 12, 16, 20, and 24 weeks (phase 2)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): HAMD-17 time between baseline and occurence of relapse<br>Beck Depression Inventory (BDI)<br>Clinical Global Impression (CGI);Timepoint(s) of evaluation of this end point: 0, 4, 8, 12, 16, 20, and 24 weeks (phase 2)