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Tests treatment safety and results for Depression
Official title Study the Efficacy and Safety of the INtegral Cognitive REMediation Program (INCREM) for Depression
ClinicalTrials.gov ID: NCT06590025
What this study is testing
- What it's testing
- Feeling sad about negative or stressful events has nothing to do with the diagnosis of depression, as this is a very prevalent mental illness among the population with devastating consequences for the person suffering from it. Symptoms range from mood swings, extreme sadness, apathy, inability to feel pleasure, to sleep problems, eating disorders, physical problems, and more.
- Phase 3: a large, late-stage study
- 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 and older
You may be able to join if
- Patients aged 18 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17)
- showing cognitive symptoms (scores below 80 on the SCIP)
- with functional difficulties (scores above 12 on the FAST).
You likely can't join if
- IQ below 85;
- any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
- being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants...
- use of systemic antibiotics the last 2 months;
- presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
- for bipolar disorders, presence of a manic or mixed episodes in the last three months;
See the full eligibility criteria
- Patients aged 18 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17)
- showing cognitive symptoms (scores below 80 on the SCIP)
- with functional difficulties (scores above 12 on the FAST).
- IQ below 85;
- any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
- being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and...
- use of systemic antibiotics the last 2 months;
- presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
- for bipolar disorders, presence of a manic or mixed episodes in the last three months;
- accomplish criteria for severe treatment resistant depression;
- patients who had received electroconvulsive therapy in the previous year;
- patients receiving any other structured psychological intervention in the 3 months prior to the study;
- not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Catalonia, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Catalonia, Spain. 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.