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New treatment option for Bipolar Depression
Official title PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
ClinicalTrials.gov ID: NCT06488573
What this study is testing
- What it's testing
- Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Clinical diagnosis of Bipolar disorder types I and II diagnosis
- Adults of both genders, from 18 to 60 years old
- In typical pharmacotherapy for BD, for at least one month
- Agreement to participate in the study with signature of the consent form
You likely can't join if
- Patients with "very good or excellent" diet quality assessed by the diet quality scale (ESQUADA): \>275 out of a score of 375
- Patients in a state of hypomania or mania: score \>8 (Young Mania Rating Scale - YMRS)
- Patients with severe depression \>21 Montgomery-Åsberg Depression Rating Scale
- Patients at low cardiovascular risk (\<7 points for men or \<9 points for women on the Framingham Global Risk Score)
- Low weight or eutrophic body mass index: \<25kg/m² as in similar studies
- Pregnant or breastfeeding women
See the full eligibility criteria
- Clinical diagnosis of Bipolar disorder types I and II diagnosis
- Adults of both genders, from 18 to 60 years old
- In typical pharmacotherapy for BD, for at least one month
- Agreement to participate in the study with signature of the consent form
- Patients with "very good or excellent" diet quality assessed by the diet quality scale (ESQUADA): \>275 out of a score of 375
- Patients in a state of hypomania or mania: score \>8 (Young Mania Rating Scale - YMRS)
- Patients with severe depression \>21 Montgomery-Åsberg Depression Rating Scale
- Patients at low cardiovascular risk (\<7 points for men or \<9 points for women on the Framingham Global Risk Score)
- Low weight or eutrophic body mass index: \<25kg/m² as in similar studies
- Pregnant or breastfeeding women
- Patients diagnosed with anorexia and bulimia nervosa
- Patientes diagnosed with Irritable Bowl Syndrome or other diagnosed conditions that affect the gastrointestinal function
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.