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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00844194
Eligibility Criteria:
Inclusion criteria:
1. Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
2. To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
3. Male or female outpatients at least 18 years of age.
4. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
5. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
6. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Exclusion criteria:
1. Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
2. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
3. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
4. Have previously been treated with duloxetine (for DPNP or MDD)
5. Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
6. Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00844194
Study Brief:
Protocol Section:
NCT00844194