Taking into account the challenges related to treatment of MDD in a PCP setting, a MDD assessment tool for PCPs will be developed with a twofold intent: a) to help PCPs to follow the progress of their MDD patients from the start of the AD treatment…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study will be twofold:
A. To assess website feasibility, usability, and data quality of a web-based
major depressive disorder assessment tool. Feasibility will be evaluated by
means of the inclusion rate of patients starting an antidepressant and the time
to patient*s drop out from the web-based tool. Usability will be assessed by
means of the patient*s evaluation of the easiness of use, the actual and
perceived length of the web-sessions, and the appropriateness of the website as
a communication tool with the doctor. Data quality will be evaluated through
the completeness of entries.
B. To validate the overall prognostic value of the web-based assessment tool in
relation to three targeted outcomes: a) remission, b) non-remission with
minimal response, and c) non-response 3 and 6 months after starting the
antidepressant monotherapy.
Secondary outcome
The secondary objectives of this study are:
1. To measure and compare the specific prognostic value of the different
variables included in the MDD assessment tool in relation to the three targeted
outcomes (remission, nonremission with minimal response and non-response).
These variables are the following:
- demographic variables
- disease history
- initiated class of antidepressant - patient-reported adherence to treatment
- improvement and speed of improvement in depressive, anxious, and physical
symptoms, as well as degree of disability (i.e. functioning).
2. To measure and compare the prognostic value of the different variables
included in the MDD assessment tool in relation to two other targeted outcomes:
functional recovery and non-recovery at 3 and 6 months.
3. To analyze the functional and health economic burden of patients in
remission, nonremission with minimal response and non-response at 3 and 6
months.
4. To analyze the depressive symptoms as measured by the questionnaires of
patients in remission, non-remission with minimal response and non-response at
3 and 6 months.
5. To describe discontinuation rates, reasons for discontinuation of the first
prescribed antidepressant, and treatment decisions in relation of patients in
remission, non-remission with minimal response and non-response at 3 and 6
months.
6. To explore the possibility to define outcome categories by using the
web-based questionnaires as compared to remission, non-remission with minimal
response and non-response outcome categories by standard methods at 3 and 6
months.
7. To explore primary care physicians interest in the website assessments
through a descriptive analyses of the access to the patient self-assessments
reports.
Background summary
Primary care physicians (PCPs) are responsible for the treatment of the
majority (~70-80%) of Major Depressive Disorder (MDD) patients. In usual
practice, PCPs can rarely conduct a thorough evaluation of a depressive state
or of the changes in disease state during follow-up visits. Not only time
constraints, but also the lack of validated prognostic models for depressed
patients limits the conclusions drawn from follow-up assessments necessary for
the treatment strategy. This situation has direct implications for patients*
treatment and outcomes, with depressed patients staying on the same
antidepressive (AD) treatment for long periods without achieving remission nor
gaining functional recovery.
Study objective
Taking into account the challenges related to treatment of MDD in a PCP
setting, a MDD assessment tool for PCPs will be developed with a twofold
intent:
a) to help PCPs to follow the progress of their MDD patients from the start of
the AD treatment, and
b) to calculate, for a given patient, the probabilities of three target outcome
measures at 3 and 6 months: remission, non-remission with minimal response and
non-response.
Study design
This study is an international, multi-center, 6-month, longitudinal,
prospective, observational study to develop and validate a web-based assessment
tool for MDD episodes. Potential prognostic factors will be collected by both
the physician during 4 clinical visits (at baseline, 4, 12, and 24 weeks) and
by the patient through web-based self-assessments (at baseline, week 1, week 2
and at 2 week intervals during the first 8 weeks and monthly thereafter).
Cross-validated, prognostic models will be built for three targeted MDD outcome
variables: remission, non-remission with minimal response and nonresponse at 3
and 6 months (12 and 24 weeks) after the start of the treatment.
Study burden and risks
The completion of the questionnaires can be experienced as a burden and
influence subject's mental state. This, as well as patient's spiritual
well-being is checked by the investigator at each study visit. When the
completion of the questionnaires for the patient appears to be too burdensome,
the physician will take the patient of study.
Stoofstraat 52
1000, Brussel
BE
Stoofstraat 52
1000, Brussel
BE
Listed location countries
Age
Inclusion criteria
- Male or female outpatients aged between 18-64 years
- Meeting criteria for MDD as defined by DSM-IV and about to start antidepressant monotherapy at the discretion of the primary care physician
- Having personal access to internet and being comfortable with using it (e.g. being a regular user of personal emails) as assessed by the investigator
- Having signed a consent form (and confirming this consent via the website within 48 hours after baseline visit at the doctor)
Exclusion criteria
- Patients having received any antidepressant for a depressive episode during the past 6 months
- Patients about to start combined antidepressant treatment or a combination of an antidepressant with an antipsychotic or mood stabilizer (continuation of an antiepileptic treatment is allowed)
- Have any history of bipolar disorder, psychosis, schizophrenia, or substance dependence (within the last year and with the eception of tobacco or caffeine)
- Have a history of stroke or dementia
- Being Lilly employee
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39401.028.12 |