Extent and kind of cognitieve dysfunctions in patients suffering from bipolar disorder: their determinants and impact on clinical and functional outcome

• Conditions: manic depressive disorder; bipolar disorder; 10026753

• Registration Number: NL-OMON47826
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

- MINI-plus confirmed diagnosis of bipolar disorder
- minimum age 18 years; maximum age 65 years
- IDS-SR <34 (i.e. not severly depressed) + YMRS <8 (not (hypo)manic)

Exclusion Criteria

-mental retardation
- a known systemic or neurological illness, known to affect cognitive
functioning

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is cognitive dysfunction, defined as a score of 2<br /><br>standard deviations (SD) below the average of the healthy control group in one<br /><br>of the cognitive tasks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Clinical factors: Illness characteristics (medical history (for example<br /><br>number of episodes), medication<br /><br>- Biological factor: HPA axis functioning, neuroinflammation markers and<br /><br>markers of intestinal permeability in blood<br /><br>- Outcome factors: psychosocial outcome (WHO-DAS II, ZW, RAND, WHO-Qol-Bref,<br /><br>GAF), illness outcome (course of illness (number of episodes), insight (Mood<br /><br>Disorders Insight Scale), traumatic life-events </p><br>