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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01211756
Eligibility Criteria:
Inclusion Criteria:
1. Adult men or women, 18 years of age or older.
2. Meet DSM-IV criteria for Major Depressive Disorder or Dysthymia Disorder
3. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
4. Must be on a therapeutic dose of 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
5. MADRS score of \>17 at randomization
6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
8. Must be able to use nasal spray
9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. (If patient cannot then he/she will be considered for the acute only portion of this study.)
Permitted:
Subjects on up to 2 sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.
Minor adjustments in sleep medication is acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
Exclusion Criteria:
Subjects will be excluded from the study of they meet any of the following criteria:
1. Are pregnant or are breastfeeding (negative pregnancy test at screening)
2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
4. Are unsuitable in any way to participate in this study, in the opinion of the investigator.
5. Another current DSM-IV diagnosis other than Major Depressive Disorder or Dysthymia Disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01211756
Study Brief:
Protocol Section:
NCT01211756