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Effect of citalopram on chest pain in patients with achalasia.
EU CTIS ID: 2024-517701-81-01
What this study is testing
To investigate the effect of citalopram, as compared to a placebo, on spontaneous chest pain episodes in patients with achalasia.
- 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
- Written informed consent
- Minimum age: 18 years. Maximum age: 75 years.
- Diagnosed with achalasia type 1 or 2, confirmed by high-resolution manometry
- Previously treated with pneumodilatation, Heller’s myotomy or POEM
- ≥3 months post-treatment for achalasia
- Midline chest pain or discomfort that is not of burning quality
You likely can't join if
- Achalasia type 3 (‘’spastic type’’) or spastic contractions on high-resolution manometry
- Contraindication for concomitant use with moclobemide and buspiron
- Hypersensitivity to citalopram, placebo or to any of the excipients: Lactose, mannitol, microcrystalline cellulose, colloidal silica, anhydrous, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171).
- Surgery of the esophagus except Heller’s myotomy and POEM
- Currently using antidepressants
- Chest pain suspect of cardiac origin
See the full eligibility criteria
- Written informed consent
- Minimum age: 18 years. Maximum age: 75 years.
- Diagnosed with achalasia type 1 or 2, confirmed by high-resolution manometry
- Previously treated with pneumodilatation, Heller’s myotomy or POEM
- ≥3 months post-treatment for achalasia
- Midline chest pain or discomfort that is not of burning quality
- At least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
- No significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
- At start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy (Date of last endoscopy cannot be longer than 5 years ago)
- Achalasia type 3 (‘’spastic type’’) or spastic contractions on high-resolution manometry
- Contraindication for concomitant use with moclobemide and buspiron
- Hypersensitivity to citalopram, placebo or to any of the excipients: Lactose, mannitol, microcrystalline cellulose, colloidal silica, anhydrous, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171).
- Surgery of the esophagus except Heller’s myotomy and POEM
- Currently using antidepressants
- Chest pain suspect of cardiac origin
- Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
- Pregnancy or lactation. A pregnancy test will be carried out prior to inclusion in the study. Female patients who are premenopausal and have a negative pregnancy test should be on an anticonceptive.
- Allergy to barium sulfate
- Contraindication for concomitant use of MAO-inhibitors
- Contraindication for concomitant use of drugs that prolong the QT interval: such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (such as sparfloxacin, moxifloxacin, erythromycin iv, pentaria, treatment with malaria) particular halofantrine), certain antihistamines (astemizol, mizolastine).
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.