Depressive DisorderPhase 3NCT00997490

Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)

A Phase 3 study testing Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower) and film-coated sugar-pill in people with Depressive Disorder, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Depressive Disorder
What is being tested?: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower) and film-coated sugar-pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 1 siteGermany
Study dates: Jan 2001to Feb 2003
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dr. Urlea-Schoen
Siegen, North Rhine-Westphalia, D-57072

Other trials in Germany

About this study

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

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.

Read the detailed description

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.

Conditions: Depressive Disorder
Being tested: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower), film-coated sugar-pill
Keywords: depression, HAMD 21, anxiety, HAMA, Hypericum, Valerian, Passionflower, F32.0, F33.0
Medical subject headings: Depressive Disorder, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)Drug
Also called Neurapas balance, film-coated tablet
3 x 2 tablets/day over 6 weeks
film-coated sugar-pillDrug
3 x 2 tablets / day over 6 weeks

Study groups in NCT00997490
Study group	Role	What they receive
Verum	Experimental	Neurapas balance, film-coated tablet Receives: Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)
Placebo	Placebo comparator	Not described Receives: Drug: film-coated sugar-pill

What is being measured

The primary outcome is the main question the study is designed to answer.

HAM-D 21
Measured: 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 (5)

Self-Rating Depression Scale (SDS)
Measured: V1, V2, V4, V6, V8
HAMILTON Anxiety Scale (HAM-A)
Measured: V2, V4, V6, V8
Clinical Global Impressions (CGI)
Measured: V2, V8
BULLINGER Quality of Life questionnaire (SF-36)
Measured: V2, V6, V8
Sleep questionnaire (SQ)
Measured: V2, V6, V8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Feb 2003

First posted19 Oct 2009 (estimated)
Study startJan 2001
Primary completionJul 2002
Study completionFeb 2003

Why it stopped: Clearly identifiable benefits 50% of patients included

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997490
Sponsor's protocol ID: PSC 120/99
Status last verified: May 2010
First submitted: 16 Oct 2009
Last updated: 17 May 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Placebo-controlled, Randomised, Single-centre, Double-blind Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation
ClinicalTrials.gov ID: NCT00997490
Acronym / sponsor ID: PSC 120/99
Conditions: Depressive Disorder
Keywords: depression, HAMD 21, anxiety, HAMA, Hypericum, Valerian, Passionflower, F32.0
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Clearly identifiable benefits 50% of patients included
Enrolment: 67 participants (actual)
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
Study start: Jan 2001
Primary completion: Jul 2002 (actual)
Study completion: Feb 2003 (actual)
First posted: 19 Oct 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Verum	Experimental	Drug: Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)Neurapas balance, film-coated tablet
Placebo	Placebo comparator	Drug: film-coated sugar-pill

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurapas® balance (Herbal combination out of hypericum, valerian, passionflower)Also: Neurapas balance, film-coated tablet3 x 2 tablets/day over 6 weeks	Drug	Verum
film-coated sugar-pill3 x 2 tablets / day over 6 weeks	Drug	Placebo

Primary outcome

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)

5 secondary outcomes

Self-Rating Depression Scale (SDS)
Time frame: V1, V2, V4, V6, V8
HAMILTON Anxiety Scale (HAM-A)
Time frame: V2, V4, V6, V8
Clinical Global Impressions (CGI)
Time frame: V2, V8
BULLINGER Quality of Life questionnaire (SF-36)
Time frame: V2, V6, V8
Sleep questionnaire (SQ)
Time frame: V2, V6, V8

Results and safety

The study was stopped early (reason given: Clearly identifiable benefits 50% of patients included). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ilie Urlea-Schoen, Dr med (RO) principal investigator

Anja Braschoss, MD study director

Pascoe Pharmazeutische Praeparate GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Clearly identifiable benefits 50% of patients included). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2010.