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New treatment option for Psychosis
Official title A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction
ClinicalTrials.gov ID: NCT06729671
What this study is testing
- What it's testing
- Antipsychotic drugs are used to treat a range of psychiatric disorders including schizophrenia, bipolar disorders, and psychotic depression. Most antipsychotics are associated with significant weight gain and metabolic disturbances, which increase the risks for other diseases (obesity, diabetes, coronary diseases, etc.) and negatively impact medication adherence and quality of life.
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 65
You may be able to join if
- 8.1 To be considered eligible for enrolment into the study, people must;
- Aged between 18-65 years old including women of child-bearing age
- Having a diagnosis of affective or non-affective functional psychosis defined according to ICD-10 criteria for psychosis (codes F20-30 \& F32.3)
- Patients who are able to and have given written informed consent
- Patients who are willing to provide blood samples
You likely can't join if
- Intravenous drug use
- Diagnosis of substance dependence in the past 3 months
- Pregnancy or planning a pregnancy
- Antibiotic use in the past 30 days
- Steroid use in the past 30 days
- Use of anti-coagulants, anti-inflammatory drugs, over-the counter non-steroidal anti-inflammatories (NSAIDS) and analgesics. people should have a...
See the full eligibility criteria
- 8.1 To be considered eligible for enrolment into the study, people must;
- Aged between 18-65 years old including women of child-bearing age
- Having a diagnosis of affective or non-affective functional psychosis defined according to ICD-10 criteria for psychosis (codes F20-30 \& F32.3)
- Patients who are able to and have given written informed consent
- Patients who are willing to provide blood samples
- Patients who are willing to provide saliva (cortisol) and faecal microbiome samples
- Considering the nature of the study participants, a broad spectrum of concomitant medication will be permissible. Psychotropic meds, including antidepressants, mood stabilisers (lithium, valproate, carbamazepine)...
- Intravenous drug use
- Diagnosis of substance dependence in the past 3 months
- Pregnancy or planning a pregnancy
- Antibiotic use in the past 30 days
- Steroid use in the past 30 days
- Use of anti-coagulants, anti-inflammatory drugs, over-the counter non-steroidal anti-inflammatories (NSAIDS) and analgesics. people should have a wash-out period of 4 weeks.
- Patients suffering from any clinically significant or unstable medical condition, including congestive heart failure, coeliac disease, or an immunodeficiency syndrome.
- Pre or probiotic supplements within the past 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Ireland
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cork, Ireland. 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.