ADHDPhase 3NCT00782080
Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
A Phase 3 study testing Sedariston in people with ADHD, run by Prof. Huss at 5 sites in Germany.
Trial summary
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD. Study Design: Randomized Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Placebo Control Parallel Assignment Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Sedariston
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2008to Jun 2010
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV Diagnosis of ADHD
- Score of ADHDRS-IV-Parent Version ≥24
- Sufficient knowledge of the German language
- Written Informed Consent by parents and patients
- Ability to swallow study medication
- Sexually mature and active adolescents with highly effective methods of birth control:
- contraception according to Pearl-Index < 1
- when use of oral contraceptives, additional methods of contraception (e.g. condoms) are necessary, i.e. double-barrier
Who cannot join
- Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients
- Known hypersensitivity of the skin when exposed to sunlight
- All serious internal diseases, and for this reason: Current intake of the following medication:
- Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment
- Irinotecan and other cytostatics
- anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptyline
Show all 18Show fewer
- Midazolam, Theophylline or other medication with photosensitive effects
- All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason current intake of the following medication: antidepressants and other psychotropic medication
- Indication for hospitalization
- Suicidality (including suicidal thoughts): Score ≥3 in item 10 of MADRS
- Pregnancy, lactation
- IQ < 70
- Positive screening for metabolites of illegal drugs in urine
- Previous medication with stimulants and/or atomoxetine
- Psychotropic co-medication
- Placement in an institution on official or judicial ruling
- Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago
- Patients requiring a primary medication with methylphenidate during the study period of 8 weeks
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Rheinhessenfachklinik
Alzey, 55232
DRK Fachklinik für Kinder- und Jugendpsychiatrie
Bad Neuenahr, 53474
Praxis für Kinder- und Jugendpsychiatrie
Berlin, 10789
Charité University
Berlin, 13353
Johannes Gutenberg University
Mainz, 55131
About this study
Official title: Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Study Design:
- Randomized
- Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Placebo Control
- Parallel Assignment
Read the detailed description
ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and atomoxetine naive patients. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8 weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side effects will be monitored continuously and also assessed by rating scales.
- Conditions
- ADHD
- Being tested
- Sedariston, Placebo
- Keywords
- ADHD, children, adolescents, St. John's Wort, Valerian extract, Safety, Efficacy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedaristonDrug
Also called Sedariston Concentrate(R)
St. John´s Wort (100 mg) Valerian Extract (50 mg)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sedariston | Experimental | Sedariston (100 mg St. John´s Wort and 50 mg Valerian extract) capsule given orally in capsules (size 1) twice daily for eight weeks in children (6-11): 1 - 0 -1 In Adolescents (12-17 years) two capsules (size 1) twice daily: 2 - 0 - 2. Receives: Drug: Sedariston |
| Placebo campsule | Placebo comparator | Placebo provided by the company given orally in capsules (size 1 )twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-IV rating scale
Measured: Difference in total score between baseline and end of study
Secondary outcomes (1)
Barkley´s Side Effects Rating Scale
Measured: Difference between baseline and each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Huss
- Sponsor type
- University, hospital or other
- Collaborators
- Steiner Arzneimittel, Berlin, Germany
- Responsible party
- Sponsor-investigator, Prof. Huss, Johannes Gutenberg University Mainz
- Investigators
- Michael Huss, Prof. Dr., Principal investigator, Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782080
- Sponsor's protocol ID
- Stei-Sed-0106
- Status last verified
- Mar 2014
- First submitted
- 29 Oct 2008
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00782080
- Acronym / sponsor ID
- Stei-Sed-0106
- Conditions
- ADHD
- Keywords
- ADHD, children, adolescents, St. John's Wort, Valerian extract, Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Prof. HussUniversity, hospital or other
- Collaborators
- Steiner Arzneimittel, Berlin, Germany
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Oct 2008 (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.
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Study Design:
- Randomized
- Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Placebo Control
- Parallel Assignment
Detailed description
ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and atomoxetine naive patients. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8 weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side effects will be monitored continuously and also assessed by rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedariston | Experimental | Drug: SedaristonSedariston (100 mg St. John´s Wort and 50 mg Valerian extract) capsule given orally in capsules (size 1) twice daily for eight weeks in children (6-11): 1 - 0 -1 In Adolescents (12-17 years) two capsules (size 1) twice daily: 2 - 0 - 2. |
| Placebo campsule | Placebo comparator | Drug: PlaceboPlacebo provided by the company given orally in capsules (size 1 )twice daily |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- DSM-IV Diagnosis of ADHD
- Score of ADHDRS-IV-Parent Version ≥24
- Sufficient knowledge of the German language
- Written Informed Consent by parents and patients
- Ability to swallow study medication
Key exclusion criteria (18 listed)
- Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients
- Known hypersensitivity of the skin when exposed to sunlight
- All serious internal diseases, and for this reason: Current intake of the following medication:
- All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason current intake of the following medication: antidepressants and other psychotropic medication
- Indication for hospitalization
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 |
|---|---|---|
| SedaristonAlso: Sedariston Concentrate(R)St. John´s Wort (100 mg) Valerian Extract (50 mg) | Drug | Sedariston |
| PlaceboPlacebo | Drug | Placebo campsule |
Primary outcome
ADHD-IV rating scale
Time frame: Difference in total score between baseline and end of study
1 secondary outcome
Barkley´s Side Effects Rating Scale
Time frame: Difference between baseline and each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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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.
Michael Huss, Prof. Dr. principal investigator
Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sedariston in people with ADHD, run by Prof. Huss at 5 sites in Germany.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADHD-IV rating scale (time frame: Difference in total score between baseline and end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2014.