Unknown
PHASE1
INTERVENTIONAL
NCT01239888
Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone ad-on can induce a response to antidepressants in patients with treatment resistant depression.
Detailed Description
We are examining the efficacy and safety of oxytocin or oxytocin and tibolone with an antidepressant (SSRIs) in treatment resistant depression in a double-blind randomized clinical trial. A secondary objective is the evaluation of neurobiological factors contributing to drug efficacy in treatment resistant depression.
Interventions
Name:
Oxytocin
Type:
DRUG
Description:
20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Name:
Oxytocin and Tibolone
Type:
DRUG
Description:
20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial
Name:
Placebo
Type:
DRUG
Description:
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Primary Outcomes
Measure:
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
TimeFrame:
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Description:
Trial Information
NCT ID
NCT01239888
Status
Unknown
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
The Alfred
Last Updated
December 15, 2025