Trial Condition(s):
Moderate depression
Study to compare drug Hypericumextract (made from a plant called St. John wort) with selective serotonin reuptake inhibitors (SSRI) in quality-of-life benefits and cost of treatment in patients suffering from moderate depressive episodes
Bayer Identifier:
20996
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Laif® 900, which is a drug based on Hypericumextract made from the plant St. John wort is used to treat patients suffering from moderate depressive episodes. Another drug class commonly prescribed by doctors for this group of patients is selective serotonin reuptake inhibitors (for example citalopram).
In this trial researcher want to learn how the quality of life of patients suffering from moderate depressive episodes changes when treated either with Laif® 900 or a drug from the SSRI drug class. Additionally, they also want to know if the drugs are effective, if patients are having any medical problems during the trial and how these problems will impact the overall cost of treatment. Patients participating in this trial will be followed in their routine clinical practice over a period of half a year.
Inclusion Criteria
- The patient is suffering from moderate depression. - He or she is of age. - He or she is in a position to read and understand the language and contents of the material for the medical care research study (patient information and consent form). - He or she has consented in writing to take part in the study after appropriate briefing - The patient is not pregnant. - The patient is receiving Laif® 900 or SSRIs as first-line treatment in the current episode. - The patient is receiving Laif® 900 or SSRIs as a monotherapy.
Exclusion Criteria
- Occurrence of a contraindication with respect to the current or proposed treatment regime. - Withdrawal of consent to participate in the observational study by the patient. - Non-conforming use of Laif® 900 or SSRIs.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
Healthcare and quality of life of patients with moderate depression during treatment with Laif® 900 in comparison to selective serotonin reuptake inhibitors (SSRI)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Quality of life of patients during treatment with Laif® 900 compared to SSRIsThe "SF-36 v2 Health Survey" used is a self-assessment tool across all diseases which is widely used internationally for patients with a broad range of disorders.Timeframe: up to 6 months
- Number and Intensity of AEsQuality of life will also be considered in connection with the occurrence of AEs.Timeframe: up to 6 month
- Direct CostsDirect costs are collated in four cost blocks: medical treatment costs (treatment of the depression by the documenting doctor and other doctors, as well as emergency treatments), costs of medications, costs of non-pharmacological therapies and costs of in-patient stays.Timeframe: up to 6 month
- Indirect CostsFull or partial reduced earning capacity and early retirement, as well as the periods of incapacity for work of patients who were working, were recorded and evaluated as indirect cost factors.Timeframe: up to 6 weeks
Secondary Outcome
- Effectiveness under everyday conditions of Laif® 900 in comparison to SSRIsAt the end of the healthcare research study the doctors assessed the effectiveness as very good, good, satisfactory, poor or very poor.Timeframe: at 6months
Additional Information
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