Oxytocin Add-on for Stable Depressed Patients

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Feifel
• Treatments: Oxytocin

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