Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00006157
Eligibility Criteria:
Inclusion Criteria:
* Literate, female patients aged 18-65.
* Symptoms present at least 2 days/week for greater than 6 months.
* Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria.
* Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110.
* Discontinuation of all antidepressant medications for at least 3 months.
* Use of acceptable method of birth control.
Exclusion Criteria:
* Evidence of lactose intolerance to explain bowel symptoms.
* Heart disease.
* Cardiac arrhythmias.
* Severe psychiatric disorder (e.g., bipolar, suicide attempts).
* Previous use of desipramine.
* Glaucoma.
* Urinary retention.
* Pregnancy.
* Alcohol consumption 3oz/day that would preclude participation or prevent data assessment.
* Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology.
* Bipolar disorder.
* Schizophrenia.
* Substance abuse/dependency.
* Previous use of desipramine.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00006157
Study Brief:
Protocol Section:
NCT00006157