NCT00997490

Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation

Terminated Phase 3 Last updated 14 May 2010

What this trial tests

Phase 3 trial testing Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower) in Depressive Disorder in 67 participants. Terminated before completion.

Timeline

1 January 2001

Primary endpoint
1 July 2002

1 February 2003

Quick facts

Lead sponsor	Pascoe Pharmazeutische Praeparate GmbH
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	67
Start date	1 January 2001
Primary completion	1 July 2002
Estimated completion	1 February 2003
Sites	1 location across Germany

Drugs / interventions tested

• Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower) — full drug profile →
• film-coated sugar-pill — full drug profile →

Conditions studied

• Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

Pascoe Pharmazeutische Praeparate GmbH — full company profile →

Who can join

Adults 18 to 70, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• HAM-D 21
  Time frame: Visit 1 (Start of medication), Visit 2 (End of run-in phase), Visit 4 (after 2 weeks treatment), Visit 6 (after 4 weeks treatment), Visit 8 (End of Study)

Sponsor's own description

The efficacy and tolerability of Neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode.

After a one-week placebo run-in phase to exclude placebo responders, patients were given the study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.

The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ) were used as further efficacy criteria.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Herbal Medicinal Products from <i>Passiflora</i> for Anxiety: An Unexploited Potential.
   da Fonseca LR, Rodrigues RA, Ramos AS, da Cruz JD, et al · · 2020 · cited 26× · PMID 32765195 · DOI 10.1155/2020/6598434