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Biomarkers and Mood course in Bipolar disorder in the Netherlands - a Longitudinal Cohort study (BINCO)

Biomarkers and Mood course in Bipolar disorder in the Netherlands - a Longitudinal Cohort study (BINCO) - BINCO

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50605
Enrollment
210
Registered
2016-01-07
Start date
2016-07-11
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

None listed

Sponsors

psychiatrie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients - Diagnosed with bipolar disorder type I and II according the SCID-I (diagnosis

Exclusion criteria

Exclusion criteria: Patients - Current treatment or detention under the Dutch governmental mental health act. - Participants that cannot read, speak or understand Dutch. - Aged below 18 - Diagnosed with bipolar disorder NOS or cyclothymic disorder., For MRI scanning: - Ferrous objects in or around the body (e.g. braces, glasses, pacemaker, metal fragments) - History of closed- or open-head injury - History of neurological illness or endocrinological dysfunction with CNS sequelae - Claustrophobia - History of epilepsy - Drug or alcohol abuse over a period of six months prior to the experiment , Healthy controls: - no current psychiatric disorders accorrding to the DSM IV

Design outcomes

Primary

MeasureTime frame
Primary study parameters of the current study include therapeutic outcome variables, i.e. severity of depressive (measured by the QIDS) and manic (YMRS) symptoms.

Secondary

MeasureTime frame
Secondary study parameters include psychological variables such as irritability (IS-SR), personality factors, stressors (PSS), attachment (ECR), cognitive functioning (WAIS-R), early life trauma (CTQ), symptoms of PTSD (ZIL) and daily functioning (OQ). Additionally several neurobiological variables will be assessed through blood sampling, including immuno-endocrine markers, gonadal hormones and markers of metabolic syndrome. Further, through the use of hair sampling, longitudinal assessments of cortisol levels will be conducted. Lastly, participants will also be invited to participate in an MRI substudy. The imaging brain results will be related to the longitudinal mood course and treatment response.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)