check_circleStudy Completed

Moderate depression

Bayer Identifier:

20996

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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.
  • - 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
514
Trial Dates
October 2008 - October 2009
Phase
N/A
Could I Receive a placebo
No
Products
Laif® 900 (hypericum extract STW 3-VI, BAY98-7108)
Accepts Healthy Volunteer
No

Primary Outcome

  • Quality of life of patients during treatment with Laif® 900 compared to SSRIs
    The "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.
    date_rangeTime Frame:
    up to 6 months
  • Number and Intensity of AEs
    Quality of life will also be considered in connection with the occurrence of AEs.
    date_rangeTime Frame:
    up to 6 month
  • Direct Costs
    Direct 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.
    date_rangeTime Frame:
    up to 6 month
  • Indirect Costs
    Full 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.
    date_rangeTime Frame:
    up to 6 weeks

Secondary Outcome

  • Effectiveness under everyday conditions of Laif® 900 in comparison to SSRIs
    At the end of the healthcare research study the doctors assessed the effectiveness as very good, good, satisfactory, poor or very poor.
    date_rangeTime Frame:
    at 6months

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
N/A

Additional Information

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