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Clinical trial to evaluate the relapse prevention of a hypericum extract in patients with major depression

Double blind, randomized, placebo-controlled, mulitcentric clinical trial to evaluate the relapse prevention of a hypericum extract in outdoor patients with moderate depressive episodes (major depression)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001417-26-DE
Enrollment
Unknown
Registered
2008-09-19
Start date
2009-01-22
Completion date
Unknown
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate depressive episodes

Interventions

Trade Name: Laif 900 Pharmaceutical Form: Coated tablet INN or Proposed INN: St. John's Wort Current Sponsor code: STW3-VI-212-D-2008-III-Z Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

Steigerwald Arzneimittelwerk GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Main Objective: Phase 1: Non, this phase is used for achieving responder for phase 2. 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) Beck Depression Inventory (BDI) (phase 2) Clinical Global Impressions (CGI) (phase 2);Primary end point(s): Phase 1: Non, serves only to achieve responder for phase 2. 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

MeasureTime frame
Secondary end point(s): HAMD-17 time between baseline and occurence of relapse Beck Depression Inventory (BDI) Clinical Global Impression (CGI);Timepoint(s) of evaluation of this end point: 0, 4, 8, 12, 16, 20, and 24 weeks (phase 2)—

Countries

Germany

Contacts

Public ContactMedical Science Devision

Steigerwald Arzneimittelwerk GmbH

long@steigerwald.de+4961513305 171

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026