Status:
UNKNOWN
Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)
Lead Sponsor:
Bioaraba Health Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved...
Detailed Description
Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by evaluators (the evaluator does not know the branch of treatment to which the patient belongs )to evaluate if an indi...
Eligibility Criteria
Inclusion
- Patients diagnosed with bipolar disorder type I according to the criteria of the DSM-5 manual, diagnosis made by structured interview SCID-P.
- The study includes patients with first episode and multiple episodes. At the beginning of the study they must be in euthymia, that is, there will be no current diagnosis of manic, hypomanic or depressive episode. Relapses during follow-up and the presence of subindromial symptoms at any time will not result in exclusion from the study.
- Patients may be treated with any treatment according to clinical guidelines.
- Age: 18-65 years
- Speak Spanish correctly
- Informed consent for the study of the patient
Exclusion
- Presence of organic diseases of the central nervous system (CNS) or history of head trauma with loss of consciousness
- Intellectual disability.
- Acute inflammatory disease
- Treatment with anti-inflammatory drugs during the week prior to sample taking
- Pervasive developmental disorders.
- Pregnancy and lactation
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04400630
Start Date
November 5 2019
End Date
December 31 2022
Last Update
September 16 2020
Active Locations (1)
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1
Araba University Hospital
Vitoria-Gasteiz, Alava, Spain, 01009