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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT02418195
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65
2. Physically healthy and capable of undergoing ketamine infusion
3. Willing and able to provide informed consent
4. Diagnosis of Major Depressive Episode (MDE) as determined by the Mini International Neuropsychiatric Interview (MINI) (MDD participants)
5. Hamilton Depression Rating Scale (HAM-D) 21 score ≥ 16 (MDD participants)
6. Suicide attempt occurred within past 2 weeks (MDD Participants with Suicide Attempt)
7. For the time frame of the past 7 days, Columbia-Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (MDD Participants without Suicide Attempt, with Suicidal Ideation)
8. For the time frame of the past 7 days, C-SSRS score \< 3 (MDD Participants without Suicide Attempt, without SUicidal Ideation)
Exclusion Criteria:
1. Pregnancy or lactation
2. Post-partum state (being within 2 months of delivery or miscarriage)
3. Homicide risk as determined by clinical interview
4. A lifetime history of psychotic disorder
5. Any history of dissociation or dissociative disorder
6. Bipolar disorder
7. Pervasive developmental disorder
8. Cognitive disorder
9. Cluster A personality disorder
10. Anorexia nervosa
11. Treatment with one of the following medications, known to affect the glutamate-N-methyl-D-aspartate (NMDA) receptor system (specifically: lamotrigine, acamprosate, memantine, riluzole, or lithium)
12. Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month
13. Any known hypersensitivity or serious adverse effect associated with ketamine treatment
14. Any clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction
15. Unstable angina
16. Active neoplasm in the past 6 months
17. Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
18. Chemotherapy
19. Head injury of loss of consciousness in the past 6 months
20. If the subject reports any of the following disorders:
* Rheumatoid arthritis
* Lupus erythematosus
* Autoimmune hepatitis
* Autoimmune peripheral neuropathy
* Autoimmune pancreatitis
* Behcet's disease
* Chrohn's disease
* Autoimmune glomerulonephritis
* Grave's disease
* Guillain-Barre syndrome (if active)
* Hashimoto's thyroiditis
* Autoimmune polymyositis or polymyalgia (fibromyalgia is OK)
* Myasthenia gravis
* Narcolepsy
* Polyarteritis nodosa
* Scleroderma
* Sjogren's syndrome
* Transverse myelitis
* Wegener's granulomatosis
* HIstory of seizures (only childhood febrile seizures allowed)
* (HIV and Hepatitis are OK if stable)
21. Systolic blood pressure \> 150 and/or diastolic blood pressure \>90 at screening
22. A Corrected QT Interval (QTc) \> 480 msec as determined by an ECG
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02418195
Study Brief:
Protocol Section:
NCT02418195