Clinical trial: Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial (NCT01269788)

Eligibility criteria:
Inclusion Criteria:

          -  age above 18 and below 60 years old

          -  experiencing heartburn during last 6 months before inclusion

          -  experiencing heartburn during at least 4 of 7 days before inclusion

          -  presence of normal mucosa in upper gastrointestinal(GI) endoscopy which has been
             documented during 7 days before inclusion provided that the patient has not
             administered any PPI during last 30 days before inclusion

        Exclusion Criteria:

          -  inability to undergone upper GI endoscopy or PH monitoring

          -  presence of barret's esophagus or erosive esophagitis in upper GI endoscopy

          -  presence of active peptic ulcer disease or any disease which affects the absorption of
             drugs such as inflammatory bowel disease

          -  past history of esophageal or gastric surgery

          -  esophageal stricture which needs dilation

          -  administration of proton pomp inhibitors during 30 days before inclusion to the study

          -  administration of H2 blockers, anticholinergics, sucralfate and pro-kinetics during
             the assessments for eligibility and also during the study

          -  long time administration of non-steroidal anti-inflammatory drugs (NSAIDs)

          -  administration of neuroleptic or antidepressant drugs during 30 days before inclusion
             to the study

          -  known allergy to PPIs or SSRIs

          -  presence of significant systemic disease such as scleroderma , diabet mellitus ,
             peripheral and autonomic neuropathies and ...

          -  pregnancy for females

          -  presence of known psychiatric disorder such as depression , panic disorder or drug
             addiction according to the DSM-IV criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0