DepressionPhase 4NCT00557427
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
A Phase 4 study testing hypericum and fluoxetine in people with Depression, run by Rafa Laboratories at 1 site in Israel.
Trial summary
The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- hypericum and fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Nov 2010
- Phase
- Phase 4
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Adolescents aged 12 to 18 years
- Patients meeting the criteria for mild to moderate depression according to the DSM-IV scale
- Physical and laboratory examination at baseline compatible with study criteria
- ECG at baseline compatible with study criteria
- Score of at least 40 on the Children's Depression Rating Scale - Revised (CDRS-R) at baseline
Who cannot join
- Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder
- Patients with epilepsy
- Patients with a history of alcohol or substance abuse in the past year
- Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study.
- Patients who have previously failed to respond to SSRI's or SRNI's
- Patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine)
- Patients with a contraindication to taking either Remotiv or fluoxetine or taking medication contraindicated when taking Remotiv or fluoxetine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-labeled Randomized Comparative Study of the Efficacy and Tolerability of Two Times Daily 250mg Hypericum Versus Once Daily 20 - 40 mg Fluoxetine in Adolescent Patients With Mild to Moderate Depression
The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests, urinalysis and ECG.
- Conditions
- Depression
- Being tested
- hypericum, fluoxetine
- Keywords
- mild to moderate depression according to the DSM-IV scale
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypericumDrug
Also called Remotiv
250mg tablets twice daily for 8 weeks
fluoxetineDrug
20mg - 40mg daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | hypericum 250mg tablets twice daily for 8 weeks Receives: Drug: hypericum |
| B | Active comparator | fluoxetine 20mg - 40mg daily for 8 weeks Receives: Drug: fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
Measured: 8 weeks
Secondary outcomes (4)
Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
Measured: 8 weeks
Final mean CDRS-R score
Measured: 8 weeks
Change in CDRS-R score
Measured: 8 weeks
Time to clinical response
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafa Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Apter, MD, Principal investigator, Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557427
- Sponsor's protocol ID
- REM-1/MDA
- Other IDs
- REM-1/MDA
- Status last verified
- Jun 2011
- First submitted
- 13 Nov 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14. doi: 10.1097/01.CHI.0000046900.27264.2A.
PubMed 12874492Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301. doi: 10.1089/cap.2005.15.293.
PubMed 15910213
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled Randomized Comparative Study of the Efficacy and Tolerability of Two Times Daily 250mg Hypericum Versus Once Daily 20 - 40 mg Fluoxetine in Adolescent Patients With Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT00557427
- Acronym / sponsor ID
- REM-1/MDA
- Conditions
- Depression
- Keywords
- mild to moderate depression according to the DSM-IV scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rafa LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Nov 2007 (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 study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests, urinalysis and ECG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: hypericumhypericum 250mg tablets twice daily for 8 weeks |
| B | Active comparator | Drug: fluoxetinefluoxetine 20mg - 40mg daily for 8 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Adolescents aged 12 to 18 years
- Patients meeting the criteria for mild to moderate depression according to the DSM-IV scale
- Physical and laboratory examination at baseline compatible with study criteria
- ECG at baseline compatible with study criteria
Key exclusion criteria (7 listed)
- Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder
- Patients with epilepsy
- Patients with a history of alcohol or substance abuse in the past year
- Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study.
- Patients who have previously failed to respond to SSRI's or SRNI's
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 |
|---|---|---|
| hypericumAlso: Remotiv250mg tablets twice daily for 8 weeks | Drug | A |
| fluoxetine20mg - 40mg daily for 8 weeks | Drug | B |
Primary outcome
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
Time frame: 8 weeks
4 secondary outcomes
Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
Time frame: 8 weeks
Final mean CDRS-R score
Time frame: 8 weeks
Change in CDRS-R score
Time frame: 8 weeks
Time to clinical response
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Results publication: PubMed 12874492Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14. doi: 10.1097/01.CHI.0000046900.27264.2A.
- Results publication: PubMed 15910213Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301. doi: 10.1089/cap.2005.15.293.
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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.
Alan Apter, MD principal investigator
Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypericum and fluoxetine in people with Depression, run by Rafa Laboratories at 1 site in Israel.
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 7 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 27 Jun 2011. 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 Israel. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Lack of enrollment). 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?
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit (time frame: 8 weeks). 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 NCT00557427, which also lists 2 linked publications.
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 27 Jun 2011.