Primary objective: To investigate changes in biological and psychological markers for patients with an unipolar depressive disorder during treatment.. In specific, we will study the relationship between depressive symptomatology with changes in…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
biologische markers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the relationship between change in depressive
symptomatology with change in microbioom compositions.
Secondary outcome
Secondary outcomes are relationships between change in depressive symptoms and
changes in other biological and psychological markers, including oral
microbiota, blood serum, ecological momentary assessment, and psychological
questionnaires.
Background summary
Recent advances in psychiatric research indicate a potential vital role of some
biological markers, including faecal and oral microbiota, in the development
and continuation of depressive disorders. These markers may therefore be
related to treatment (non-)response in patients with depressive disorders.
Study objective
Primary objective: To investigate changes in biological and psychological
markers for patients with an unipolar depressive disorder during treatment.. In
specific, we will study the relationship between depressive symptomatology
with changes in faecal and oral microbiota markers.
Secondary objective: To investigate the relationship between changes in
depressive symptoms with changes in other biological markers (blood serum
markers and cortisol levels); and psychological markers; that are assessed
before and after treatment.
Study design
An observational, prospective, longitudinal, cohort study.
Study burden and risks
There are negligible risks associated with participation. The burden of
participation is an assessment of two hours at the start and end of the study,
four hours in total. This includes twice a faecal and oral sample,
questionnaire assessment, and short questions through a mobile phone app during
eight weeks, three times a day.
Meibergdreef 8
Amsterdam 1105AZ
NL
Meibergdreef 8
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patient is eligble for participation when he/she: 1) will start neuromodulation
treatment or psychotherapy (behavioural activation) at the AMC, department of
Psychiatry, mood disorders; 2) has not started the treatment yet; 3) is
diagnosed with a unipolar depressive disorder; 4) is older than 18 years.
Exclusion criteria
Co-morbid psychiatric disorders are accepted, except for schizophrenia,
psychosis, and unstable high risk patients with acute hightened risk of
suicide. If the main diagnosis of MDD is missing, the patient is not eligible.
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 | NL66854.018.19 |