NCT01239888

Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study

Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Alfred · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Oxytocin	20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
DRUG	Oxytocin and Tibolone	20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial
DRUG	Placebo	20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-11-01
• First posted: 2010-11-15
• Last updated: 2012-01-18

Locations

1 site across 1 country: Australia