Primary Objective: To identify immuno-endocrine and neuro-imaging parameters differentiating between different mood states (manic, depressive, and euthymic). Secondary Objectives: 1. To identify the influence of these parameters on the onset and…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters of the current study include therapeutic outcome
variables, i.e. severity of depressive (measured by the QIDS) and manic (YMRS)
symptoms.
Secondary outcome
Secondary study parameters include psychological variables such as irritability
(IS-SR), personality factors, stressors (PSS), attachment (ECR), cognitive
functioning (WAIS-R), early life trauma (CTQ), symptoms of PTSD (ZIL) and daily
functioning (OQ).
Additionally several neurobiological variables will be assessed through blood
sampling, including immuno-endocrine markers, gonadal hormones and markers of
metabolic syndrome.
Further, through the use of hair sampling, longitudinal assessments of cortisol
levels will be conducted.
Lastly, participants will also be invited to participate in an MRI substudy.
The imaging brain results will be related to the longitudinal mood course and
treatment response.
Background summary
Bipolar disorder is a chronic disabling disease with an intermittent course and
constitutes a serious burden on patients, family and society. One of the main
problems in the treatment of patients with a bipolar disorder is how little is
known about the underlying (biological) mechanisms that contribute to the
complex interplay between the environment (e.g. stressful events, trauma) and
severity and recurrence of mood episodes. Knowledge about the neurobiology
underlying mood episodes in bipolar disorder is highly needed in order to
improve the quality of care for these patients.
Study objective
Primary Objective:
To identify immuno-endocrine and neuro-imaging parameters differentiating
between different mood states (manic, depressive, and euthymic).
Secondary Objectives:
1. To identify the influence of these parameters on the onset and course of new
mood episodes.
2. To identify biological parameters differentiating in risk of relapse in the
course of bipolar disorder.
3. To identify neuroendocrine, immunological an neuro-imaging mechanisms
involved in the onset and course of mood episodes compared to stable periods.
4. To identify the influence of life style factors such as dietary intake
components, and gut microbiota on mood state.
5. To identify the influence of sex hormones on mood episodes
6. To identify the relation of cognitive functioning on relapse risk
Study design
This study is a longitudinal naturalistic study, with a prospective cohort
study design. Patients with bipolar disorder will be followed during 1 year,
which will be extended coming years.
Study burden and risks
The main study parameters are assessed using standardized self-rating
questionnaires as well as periodical blood and hair sampling. As such, the
overall risks associated with participation are minimal for the individual.
There is no benefit for the individual patients, but the potential benefit to
society and wellbeing for patients with a bipolar disorder can be considerable.
Max Euwelaan 70
Rotterdam 3062MA
NL
Max Euwelaan 70
Rotterdam 3062MA
NL
Listed location countries
Age
Inclusion criteria
Patients
- Diagnosed with bipolar disorder type I and II according the SCID-I (diagnosis
< 1 year)
- Aged above 18 , One of out of 2 criteria below:
- Start of specialized outpatient treatment
- Admission due to depression or mania, Healthy controls:
-matched on age and gender with patient population
Exclusion criteria
Patients
- Current treatment or detention under the Dutch governmental mental health
act.
- Participants that cannot read, speak or understand Dutch.
- Aged below 18
- Diagnosed with bipolar disorder NOS or cyclothymic disorder., For MRI
scanning:
- Ferrous objects in or around the body (e.g. braces, glasses, pacemaker, metal
fragments)
- History of closed- or open-head injury
- History of neurological illness or endocrinological dysfunction with CNS
sequelae
- Claustrophobia
- History of epilepsy
- Drug or alcohol abuse over a period of six months prior to the experiment ,
Healthy controls:
- no current psychiatric disorders accorrding to the DSM IV
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL51776.058.14 |