Study of the Antidepressant Efficacy of a Combination Her... | NCT00997490

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Clearly identifiable benefits 50% of patients included

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Jul 2002Actual

Completion Date

Feb 2003Actual

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Oct 16, 2009

First Posted Date

Oct 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2010

Last Update Posted Date

May 17, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Pascoe Pharmazeutische Praeparate GmbHINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed 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 according to ICD 10, F32.0 and F33.0.

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 study was conducted in accordance with the relevant requirements of the German Medicines Act (AMG), the Declaration of Helsinki (48th General Assembly, Sommerset West, Rep. of South Africa, October 1996) and ICH GCP guidelines.

The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21 (primary efficacy criterion). 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 secondary efficacy criteria.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verum	Experimental	Neurapas balance, film-coated tablet	Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
Placebo	Placebo Comparator		Drug: film-coated sugar-pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)	Drug	3 x 2 tablets/day over 6 weeks	Verum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HAM-D 21		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)

Secondary Outcomes

Measure	Description	Time Frame
Self-Rating Depression Scale (SDS)		V1, V2, V4, V6, V8
HAMILTON Anxiety Scale (HAM-A)		V2, V4, V6, V8
Clinical Global Impressions (CGI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Depressive symptoms of mild intensity, as defined in the International Classification of Mental Disorders (ICD 10), codes F32.0 (mild depressive episode) and F33.0 (recurrent depressive disorder, current episode mild)
SDS Index between 51 and 59 (this criterion was declared null and void on 21.02.02 in the 2nd Amendment)
HAM-D21 scores between 10 and 17
Between 18 and 70 years of age
Duration of depression: not less than 4 weeks and not longer than 2 years
Signed informed consent to take part in the clinical study after verbal and written information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ilie Urlea-Schoen, Dr med (RO)		Principal Investigator
Anja Braschoss, MD	Pascoe Pharmazeutische Praeparate GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Urlea-Schoen		Siegen	North Rhine-Westphalia	D-57072	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior