The Bipolar Lithium Imaging Scan Study: imaging lithium in the brain of BD patients.

Lithium treatment is considered the first option in pharmacological treatment
of bipolar disorder (BD). Individual responses however vary greatly, which
undermines rapid stabilization in many BD-patients. Novel developments in
neuro-imaging enable us to determine the concentration and distribution
patterns of lithium in the brains of BD-patients. These highly specialized
neuro-imaging data are not yet available and is expected to provide
groundbreaking information on how lithium exerts its therapeutic effects,
thereby potentially increasing the current moderate success rates of lithium
treatment.

Primary Objective:
To confirm that the lithium headcoil is capable of measuring lithium signals
related to clinical doses in the brains of BD patients (MDR, art 82), and then
to establish the correlation of neuroimaging data of lithium concentrations in
the brain of BD patients with longitudinal clinical lithium treatment outcome
measures.

Secondary Objectives:
To establish the correlation of neuroimaging data from 7T lithium-MRSI in BD
patients with serum lithium levels.

We will perform 7T lithium-MRSI in BD-patients who have recently (i.e within 2
weeks) started with lithium as part of their regular treatment protocol.
Subjects will be recruited from an already ongoing longitudinal naturalistic
cohort-study (BINCO-study). As soon as participants in the BINCO-study start to
prepare for lithium treatment as part of their regular treatment protocol, they
will be invited for a separate informed consent procedure for the current
study.

After the informed consent procedure and within 2 weeks of reaching therapeutic
blood levels of lithium, study subjects will undergo one 7T lithium MRSI scan
at our scan facility at LUMC.

At the same day;
- blood will be drawn to determine lithium serum levels and
- two validated, short questionnaires addressing actual mental state will be
carried out: the Young Mania Rating Scale (YMRS; Young et al, 1978) and Quick
Inventory of Depressive Symptoms (QIDS; Rush et al, 2003).

Longitudinal clinical lithium treatment outcome will be assessed using the
Retrospective Criteria of Long-term Treatment Response in Research Subjects
With Bipolar Disorder scale, also known as the ALDA scale (Manchia et al,
2013). This assessment will take place as part of the BINCO-study at 12 months
follow up.


In the process of writing this protocol, we have asked and received input of
the chair of the patient organization for BD patients in the Netherlands,
ensuring patient participation on several (non-technical) aspects in the
current protocol.

Subjects will undergo 7T lithium MRS imaging. Risks are estimated as very low:
please refer to the separate IMDDs as part of this submission. Participants
will not benefit directly from 7T lithium MRS imaging.