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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01165294
Eligibility Criteria:
Inclusion Criteria:
* Normal ECG and safety assessments, or minor no-relevant deviations, at screening
* Vital signs: systolic between 100 and 140 mmHg and diastolic between 50 and 90 mmHg and heart rate between 45 and 90 beats/min
* No medication intake in the last four weeks
* Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to adhere to the prohibitions and restrictions specified in the protocol
* Negative drug screen
Exclusion Criteria:
* Participation in another clinical trial in the last 3 months
* Significant allergies, allergic diathesis or known hypersensitivity for ketamine or its ingredients (ie, Benzethonium chloride)
* History of or current significant respiratory disease, cardiovascular disease, endocrinological, gastrointestinal, neurological, glaucoma and known liver and kidney failure
* Contraindications for an MRI being performed (claustrophobia, metal parts, pacemaker)
* oxygen saturation pO2 \< 90 mmHg
* Clinically significant abnormalities in ECG or laboratory values
* Recent history (within previous 6 months) of alcohol or drug abuse
* History of or current psychiatric diagnoses (DSM-IV, II) or neurological disorders
* Relatives in first or second degree with a schizophrenic disorder
* Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies
* Signs of hyperthyroidism based on the determination of T3, T4 and TSH
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01165294
Study Brief:
Protocol Section:
NCT01165294