Healthy volunteers Bipolar patients type 1 MedDRA version: 14.1 Level: LLT Classification code 10043890 Term: Tiredness System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: LLT Classification code 10028821 Term: Nausea with vomiting System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10013575 Term: Dizziness and giddiness System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Quilonum retard 450 mg Retard Tablets
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Lithium Carbonate
CAS Number: 554-13-2
Other descriptive name: LITHIUM CARBONATE
Co
Sponsors
Forschungszentrum Jülich GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all volunteers: blood examinations (normal level) thyroidal parameters (normal level) ECG (normal level) negative drug screening in urine (Benzodiazepine, Opiate, Amphetamine, Cannabis) no nephrological or thyroidal diseases in the medical history no metal in the human body no tattoos no retainer Age between 18 and 60 years body weight > 50 kg For women: pregnancy test negative For bipolar patients with Lithium rehabilitation: Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria euthymic condition monotherapy with Lithium Lithium therapy at least for 12 months (familiar preparation, no change to another preparation) For bipolar patients - Lithium naive: Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria euthymic condition no Lithium medication in the past no other medication for the mood treatment For healthy volunteers: no first degree relatives with psychiatric diseases in the past no psychiatric or neurological diseases in the past Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Volunteers and patients, who are not in the suitable condition for the informed consent - pregnancy - volunteers and patients before they have reached the majority age - persons with an exposure dose to 20 mSv during the last year - persons with an exposure dose to 400 mSv during the whole life - bipolar patients with psychiatric comorbidity like dependence, personality disorder or psychotic symptoms - persons, who were in a static magnetic field of 9,4T longer than 24 hours during the last year magnetic metal implants, contraceptive coil, tattoos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A powerful tool in the treatment of bipolar disorder is lithium. On a molecular level modulation of the protein kinase B and glycogen synthase kinase 3 signalling pathway by various G-protein coupled receptors has been discussed. Dopamine and serotonine receptors play a major role. In humans these two transmitter systems are accessible via PET. Emotional and cognitive functions can non-invasively be explored by fMRI. With MR-spectroscopy at ultra-high field lithium in the brain becomes quantitatively assessable. Imaging at ultra-high fields also opens up avenues for advanced sodium imaging. One hypothesis about the efficacy of lithium states that it balances the intracellular sodium concentration. A multimodal imaging approach is required to elucidate lithium working mechanisms. Our bilateral project aims to elucidate the pathophysiology of lithium in 40 healthy volun-teers (20m/20f) and 40 euthymic bipolar patients type 1 (20m/20f, 2 groups: monotherapy with lithium / lithium naive).;Secondary Objective: not applicable;Primary end point(s): Healthy volunteers: Multi modal imaging results before and after Lithium Patient group 1 bipolar on Lithium: Multi modal results during Lithium therapy Patient group 2 bipolar without Lithium: Multi modal imaging results without Lithium therapy ;Timepoint(s) of evaluation of this end point: Healthy volunteers: before intake of Lithium and after 10 days intake of Lithium Patient group1 on medication with lithium: at inclusion Patient group 2 without Lithium: at inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): no;Timepoint(s) of evaluation of this end point: no | — |
Countries
Germany
Contacts
Public ContactProf. Dr. N. J. Shah
Forschungszentrum Jülich GmbH
Outcome results
None listed