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Citalopram for reflux hypersensitivity and functional heartburn
EU CTIS ID: 2024-517019-57-00
What this study is testing
To assess the efficacy of citalopram 20 mg 8 weeks add-on treatment in patients with reflux hypersensitivity or functional heartburn and an incomplete response to PPI therapy
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 to 65 years old.
- History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
- Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
- pH-impedance values: AET ≤4% and ≤80 reflux episodes on the first 24h pH-impedance measurement
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
You likely can't join if
- Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- Pregnancy or breast feeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- Systemic diseases, known to affect esophageal motility.
See the full eligibility criteria
- 18 to 65 years old.
- History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
- Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
- pH-impedance values: AET ≤4% and ≤80 reflux episodes on the first 24h pH-impedance measurement
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
- Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- Pregnancy or breast feeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- Systemic diseases, known to affect esophageal motility.
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- QTc >450 ms
- Treatment with SSRI’s prior to the start of the study.
- Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics or medications that increase the risk of a serotoninergic syndrome
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- Major psychiatric disorder.
- Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.