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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01418651
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients.
* Age 65 years or older.
* Fibromyalgia diagnosed according to ACR 1990 criteria.
* Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
* Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.
Exclusion Criteria:
* Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
* Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
* Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
* Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (\> 450 msec).
* Uncontrolled narrow angle glaucoma.
* History of seizures.
* Use of MAO inhibitor drugs within the last 14 days.
* Abnormal baseline liver or renal function tests.
* Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
* Obstructive uropathy in males.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01418651
Study Brief:
Protocol Section:
NCT01418651