The main goal of this study is to recruit and obtain magnetic resonance images in a large sample of bipolar patients and controls from the Netherlands, in order to find brain abnormalities specific for bipolar disorder. We will also perform genetic…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main studyparameter is structural abnormalities in the brain of bipolar
patients, compared to unrelated healthy controls.
These structural differences will be measured by;
- Brain volume (sMRI) and density (voxelbased morphometry)
- Fractional anisotropy and magnetisation transfer ratio
Secondary outcome
The secondary parameter is data that associates the structural data with
genetic data.
Furthermore, we will also study baseline values or parameters which might
intervene with the main study parameter, like age, gender, years of education,
symptoms, level of functioning, medication intake and life events. We are
mainly interested in the effect op medication on the bipolar brain.
Background summary
Bipolar disorder is a complex psychiatric trait with unknown etiology. In
addition to genome wide association studies, it is important to investigate
other possible phenotypes of bipolar disorder. Endophenotypes are measurable
intermediate phenotypes that are generally closer to the action of the gene and
therefore easier to notice. Structural brain abnormalities are associated with
bipolar disorder and can provide such an intermediate phenotype of bipolar
disorder.
Study objective
The main goal of this study is to recruit and obtain magnetic resonance images
in a large sample of bipolar patients and controls from the Netherlands, in
order to find brain abnormalities specific for bipolar disorder. We will also
perform genetic imaging to identify the genes that regulate brain architecture
and investigate how brain abnormalities are associated with the genetic
susceptibility to bipolar disorder. Furthermore we would also like to
investigate the effects of medication on the brains of patients. This might
shed a light on the effects of lithium and other drugs on the bipolar brain.
Study design
In this case control study we compare measures of brain structure obtained with
Magnetic Resonance Imaging in 300 bipolar patients with 300 healthy controls
and investigate association to genome wide genotype information obtained in a
large genome wide association study.
Four years are needed to complete recruitment, scanning and sample collection
of all the subjects. Statistical analyses are initiated in the fourth year and
continue in year five.
Study burden and risks
The risks associated with participation and the benefits to the individual are
felt to be minimal. MRI is a non-invasive technique, with no known risks for
the participants. Participation will take 1.5 hours. Besides financial
remuneration, no immediate benefits are to be expected from participation in
this study for the subjects themselves. However, for society, increased
understanding of the underlying causes of BD and the genetics and brain
processes involved in BD may contribute to diagnosis, early detection and/or
prediction of treatment outcome.
As the project involves minimal risk to participants, and as the potential
benefits in terms of knowledge gained are quite large, the benefits clearly
outweigh the risks.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with bipolar disorder
- A diagnosis of BD-I according to the DSM IV, with at least one clinical intervention for mania (DSM-IV criteria)
- No history of Cognitive Disorder (DSM-IV criteria)
- Age >= 18 years
- Dutch ancestry (at least three of the four grandparents from the Netherlands);Healthy controls
- Age >= 18 years
- Dutch ancestry (at least three of the four grandparents from the Netherlands)
- No history of bipolar disorder, schizophrenia or other psychotic disorder (DSM-IV criteria)
- No first degree relative with a history of bipolar disorder, schizophrenia or other psychotic disorders (DSM-IV criteria), on the basis of a FIGS interview
Exclusion criteria
- Premorbid IQ < 80
- Did not give written informed consent
- Ferrous objects in or around the body
- Drug or alcohol abuse over a period of six months prior to the experiment (DSM-IV criteria)
- History of closed-head injury
- History of neurological illness or endocrinological dysfunction
- Claustrophobia
- Severe medical illness
- Current treatment or detention under the Dutch governmental mental health act.
- Participants that cannot read, speak or understand Dutch.
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 | NL34555.041.10 |