Investigation of the drug Lithium with Brain Imaging in people with Bipolar Disorder

• Conditions: Healthy volunteersBipolar patients type 1; MedDRA version: 14.1Level: LLTClassification code 10043890Term: TirednessSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: LLTClassification code 10028821Term: Nausea with vomitingSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: LLTClassification code 10013575Term: Dizziness and giddinessSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10051385Term: Drug-induced headacheSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10021689Term: Increased thirstSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: LLTClassification code 10036164Term: Poor weight gainSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10044577Term: Tremor of handsSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10027176Term: Memory lossSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-000778-46-DE
• Lead Sponsor: Forschungszentrum Jülich GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-18
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified