Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT05064995
Eligibility Criteria:
Inclusion criteria:
* Pat. with bipolar disorder, with an age between 18 and 85 years.
* Euthymic/ maximum mildly depressed at the time of consent (for this, the severity of depression will be determined using the Hamilton Depression Scale, this will also be included in any calculations).
Exclusion criteria:
* Pat. refuses participation
* Currently severely depressed/manic episode at the time of consent
* Other currently active severe mental/ brain organic disease (epilepsy, brain tumor..)
* St.p. severe craniocerebral trauma/ brain surgery.
* Reduced intelligence (IQ\< 70)
* Moderate/ severe dementia (Mini Mental Status Examination, MMSE, 20 and above)
* Clearly substance-induced clinical picture
Inclusion criteria healthy controls:
* For the whole procedure, made controls (age, gender) are needed. For this purpose we recruit controls by word of mouth or ask relatives of bipolar patients if they would like to participate. Patients are tested for the presence of a possible mental illness using Mini-DIPS (Diagnostisches Interview bei psychischen Störungen)
* Inclusion criteria: 18-75 years, no severe mental illness (depression, mania, psychosis; severe anxiety or obsessive-compulsive disorder requiring treatment, addictive disorder other than nicotine).
Exclusion criteria:
* First-degree relatives with severe mental illness.
* Severe active drug dependence (i.e. alcohol, benzodiazepines morphines)
* Current major depressive/ manic episode
* Other currently active severe mental/ brain illness (epilepsy, brain tumor..)
* St.p. severe craniocerebral trauma/ brain surgery.
* Congenital/ early childhood acquired intelligence impairment
* Moderate/ severe dementia (from MMSE 20)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05064995
Study Brief:
Protocol Section:
NCT05064995