MOODSTRATIFICATION is a large, multi-center international study supported by the EU. Workpackage 3 aims to establish a proof-of-concept for a succesful therapy-stratification model for use in patients with a moderate to severe depressive episode.…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Ancillary infectious topics
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is treatment response to 8 weeks of care as usual. We
define treatment response based on the improvement in the HDRS17 across this
period with a * 50% decrease in HDRS17 total score indicating full response
and a 25-49% decrease in the HDRS17 total score indicating partial response.
Secondary outcome
Secondary study endpoints are:
- changes in IDS-SR total sum score after 8 weeks.
- changes in BSS total sum score after 8 weeks.
- changes in BAI total sum score after 8 weeks.
Background summary
Psychiatric disorders are the largest cause of disability in working age
individuals in Europe, defining a major public health and economic need in our
age. Major Depressive Disorder is projected to be the second most disabling
medical condition worldwide by year 2020, and Bipolar disorder is not far
behind. Although effective therapies are available to many patients with mood
disorders in EU countries, their overall prognosis is far from optimal. One of
the major challenges is the heterogeneity in current classifications of mental
disorders in terms of both clinical aspects and underlying pathophysiological
mechanisms such as dysregulations in the immune system. Complex interactions of
socio-demographic characteristics, clinical psychiatric and somatic features
and immune system markers all influence the prognosis of depression but these
are not all systematically assessed in research and clinical practice to help
obtain more effective, personalized treatments. Especially immune system
markers seem promising as putative predictors of treatment outcome. A
substantial portion of patients with mood disorders show distortions in their
immune system, which is associated with a poor outcome of regular
antidepressant treatment and emphasizes the need for further research on the
relationship between the immune system, mood disorders and treatment.
Study objective
MOODSTRATIFICATION is a large, multi-center international study supported by
the EU. Workpackage 3 aims to establish a proof-of-concept for a succesful
therapy-stratification model for use in patients with a moderate to severe
depressive episode. The primary aim of the first phase of this study is to
systematically evaluated outcome of regular antidepressant treatment in
patients with a depressive episode and gaining more insight in the functioning
of the immune system of these patients in order to obtain more insight into the
potential benefits of stratification model. In the last 2 years of the study,
clinics will use a blood test guided approach for add-on therapy in patients
with an active depressive episode using their immune signatures. In this
protocol, we will only describe the details of the objectives and design of the
study concerning the first two years of MOODSTRATIFICATION, which will be
overseen by the university center of psychiatry in the UMCG.
Study design
A naturalistic follow-up study with a baseline assessment and follow-up
assessments at week 0, 8
and 24.
Study burden and risks
Participants will undergo a psychiatric interview and will be asked to complete
various questionnaires. At different time points during the study these
activities may be experienced as boring and/or annoying, but this constitutes a
negligible to mild burden. Patient will also deliver 50ml of blood . Taking a
single blood sample is associated with a minimal risk. The study provides no
benefits for the participants with exception of the discovery of possible
unexpected findings during the interview and or the blood test. If such a
finding is relevant for the participant, in mutual arrangement, their physician
will be informed about this finding.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Meets DSM-V criteria for MDD or BD established by MINI Plus
- Depression severity > 13 on the HDRS-17
- Age within the range of 18-65 years
- Already using an antidepressant and/or mood stabilizer without sufficient clinical response
Exclusion criteria
- Unable to provide informed consent
- Receiving care in the context of involuntary treatment and hospitalization.
- Existing or planned pregnancy or lactation
- Already participating in a other interventional study
- If at inclusion the planned next step of treatment will be ECT.
- Cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer).
- Current manic or mixed episode of bipolar disorders
- Current severe alcohol or other substance use disorder, needing treatment in a specialized setting
- Alcohol or other substance dependence in the last year which a patient needed treatment in a specialized setting.
- Current or recent (last 4 weeks) severe infectious or inflammatory disease
- Known current uncontrolled systemic disease (e.g. LE, RA)
- Known major uncontrolled metabolic disorder (e.g. diabetes, hyper- or hypothyroidism, Cushing disease of Addison disease)
- Known other significant uncontrolled somatic/organic/neurological disorder, such as or diabetes or stroke which may affect mood
- Current or recent (last 4 weeks) use of somatic medication which may affect mood or the immune system (e.g. corticoids, anti-inflammatory drugs, immune suppressive drugs)
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 | NL66772.042.18 |