The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult men or women, 18 years of age or older.
✓. Meet DSM-IV criteria for Major Depressive Disorder or Dysthymia Disorder
✓. 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.
✓. Must be on a therapeutic dose of 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
✓. MADRS score of \>17 at randomization
✓. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
✓. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
✓. Must be able to use nasal spray
Exclusion criteria
✕. Are pregnant or are breastfeeding (negative pregnancy test at screening)
✕. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
✕. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
✕. Are unsuitable in any way to participate in this study, in the opinion of the investigator.
What they're measuring
1
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)