Moderate Depressive Episodes (Major Depression)Phase 3NCT04315597
Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
A Phase 3 study testing Laif® 900, BAY98-7108 in people with Moderate Depressive Episodes (Major Depression), run by Bayer.
Trial summary
The researchers in this trial want to learn more about the drug Laif® 900 in preventing the return of signs and symptoms of depressions (also called relapse) in patients suffering from moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from the plant St. John wort. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate Depressive Episodes (Major Depression)
- What is being tested?
- Laif® 900, BAY98-7108
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2009to 22 Nov 2011
- 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
- Study Phase 1:
- Age 18-70 years
- Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression
- At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms:
- Depressed mood (main symptom)
- Loss of interest or pleasure (main symptom)
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- Significant weight loss without diet or weight gain
- Increased sleep or insomnia
- Psychomotor restlessness or slowing down
- Excessive, inappropriate guilt or feelings of worthlessness on almost every day
- Subjective or observable diminished ability to think and to decide
- Fatigue and loss of energy
- Suicidal thoughts and / or actions
- Study Phase 2:
- Phase 1 responders (= Phase 1 patients who have at least a 50% decrease in the HAMD-17 total score after 12 weeks of Laif® 900 therapy).
Who cannot join
- Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures")
- Simple mourning reaction
- Clinically relevant laboratory abnormalities due to severe organ and systemic diseases
- Taking immunosuppressants (eg after organ transplants)
- Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus)
- Thyroid dysfunction (patients with non-euthyroid TSH levels)
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- Known intolerance to the test medication
- Known photosensitivity
- Diabetes mellitus type I and II requiring treatment
- Unstable hypertension
- Pregnancy or breastfeeding
- Cancer and AIDS patients (HIV-positive)
- Alcohol, drug or drug abuse in the last 6 months
- Coadministration with coumarin-type anticoagulants
- History of epilepsy
- Melanoma
- Specific psychotherapy in the last 2 months and during the clinical trial
- Participation in a clinical trial within the last 30 days
- Simultaneous participation in another clinical trial
- Compliance and protocol management are not guaranteed by language problems
About this study
Official title: Doubleblind, Randomized, Placebo-controlled, Multicenter Clinical Study to Investigate Relaps-prevention by Hypericumextract in Outpatients With Moderate Depressive Episodes (Major Depression)
The researchers in this trial want to learn more about the drug Laif® 900 in preventing the return of signs and symptoms of depressions (also called relapse) in patients suffering from moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from the plant St. John wort. Patients will be accepted to take part in the study if they have 20-24 points on the Hamilton Depression Rating Scale (HAM-D) which is a questionnaire helping the doctor to rate the severity of the depression and includes questions on patient's mood, sleep difficulties, agitation, anxiety and weight loss. About 400 patients will be enrolled into the first part of the study and will be treated for 12 weeks with Laif® 900 capsule once daily. Only patients with an improved HAM-D score by 50% will stay in the study and continue with the second part of the study which will last for 24 weeks.
In this second part of the study patients will receive either Laif® 900 capsule once daily or an inactive tablet (placebo). Neither the treating doctor nor the patient will know which patient receives the Laif® 900 or placebo. At the end of the study the researcher will assess the effectiveness of the study drug in prevention relapse of depression episodes and will also have more information on the safety of the study drug.
- Being tested
- Laif® 900, BAY98-7108, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laif® 900, BAY98-7108Drug
1 x daily, 1 tablet, 900 mg
PlaceboDrug
1 x daily, 1 tablet, 900 mg
| Study group | Role | What they receive |
|---|---|---|
| Hypericum extract STW 3-VI (Laif® 900, BAY98-7108) | Experimental | Not described Receives: Drug: Laif® 900, BAY98-7108 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Definition: Increase of the Hamilton rating scale for depression (HAMD)-17 total score in Phase 2 by > 5 points compared to Phase 2 baseline, if at the same time a total score of at least 12 is reached.
Measured: 24 weeks
Secondary outcomes (5)
Time between baseline and occurrence of relaps measured by: Total score of HAMD-17
Measured: 24 weeks
Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)
Measured: 24 weeks
Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)
Measured: 24 weeks
Global assessment of efficacy by investigators and patients
% of investigators and patients, respectively, who rated the efficacy "very good" or "good", respectively.
Measured: 12 and 24 weeks
Safety and Tolerability: Number of Adverse Events
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start3 Mar 2009
- Primary completion22 Nov 2011
- Study completion22 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Depressive Episodes (Major Depression)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Steigerwald Arzneimittelwerk GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315597
- Sponsor's protocol ID
- 20997
- Other IDs
- 2008-001417-26, 2008
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doubleblind, Randomized, Placebo-controlled, Multicenter Clinical Study to Investigate Relaps-prevention by Hypericumextract in Outpatients With Moderate Depressive Episodes (Major Depression)
- ClinicalTrials.gov ID
- NCT04315597
- Acronym / sponsor ID
- 20997
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Steigerwald Arzneimittelwerk GmbH
- Study start
- 3 Mar 2009 (actual)
- Primary completion
- 22 Nov 2011 (actual)
- Study completion
- 22 Nov 2011 (actual)
- First posted
- 19 Mar 2020 (actual)
- 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 researchers in this trial want to learn more about the drug Laif® 900 in preventing the return of signs and symptoms of depressions (also called relapse) in patients suffering from moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from the plant St. John wort. Patients will be accepted to take part in the study if they have 20-24 points on the Hamilton Depression Rating Scale (HAM-D) which is a questionnaire helping the doctor to rate the severity of the depression and includes questions on patient's mood, sleep difficulties, agitation, anxiety and weight loss. About 400 patients will be enrolled into the first part of the study and will be treated for 12 weeks with Laif® 900 capsule once daily. Only patients with an improved HAM-D score by 50% will stay in the study and continue with the second part of the study which will last for 24 weeks.
In this second part of the study patients will receive either Laif® 900 capsule once daily or an inactive tablet (placebo). Neither the treating doctor nor the patient will know which patient receives the Laif® 900 or placebo. At the end of the study the researcher will assess the effectiveness of the study drug in prevention relapse of depression episodes and will also have more information on the safety of the study drug.
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 |
|---|---|---|
| Hypericum extract STW 3-VI (Laif® 900, BAY98-7108) | Experimental | Drug: Laif® 900, BAY98-7108 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-70 years
- Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression
- At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms:
- Depressed mood (main symptom)
- Loss of interest or pleasure (main symptom)
Key exclusion criteria (20 listed)
- Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures")
- Simple mourning reaction
- Clinically relevant laboratory abnormalities due to severe organ and systemic diseases
- Taking immunosuppressants (eg after organ transplants)
- Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus)
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 |
|---|---|---|
| Laif® 900, BAY98-71081 x daily, 1 tablet, 900 mg | Drug | Hypericum extract STW 3-VI (Laif® 900, BAY98-7108) |
| Placebo1 x daily, 1 tablet, 900 mg | Drug | Placebo |
Primary outcome
Relapse rate
Time frame: 24 weeks
Definition: Increase of the Hamilton rating scale for depression (HAMD)-17 total score in Phase 2 by > 5 points compared to Phase 2 baseline, if at the same time a total score of at least 12 is reached.
5 secondary outcomes
Time between baseline and occurrence of relaps measured by: Total score of HAMD-17
Time frame: 24 weeks
Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)
Time frame: 24 weeks
Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)
Time frame: 24 weeks
Global assessment of efficacy by investigators and patients
Time frame: 12 and 24 weeks
Safety and Tolerability: Number of Adverse Events
Time frame: 36 weeks
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 19 Mar 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laif® 900, BAY98-7108 in people with Moderate Depressive Episodes (Major Depression), run by Bayer.
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 15 inclusion and 20 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Relapse rate (time frame: 24 weeks). 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 19 Mar 2020.