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

NCT01239888 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-01-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Charlotte Keating, PhD · Monash University and the Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-11-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239888 on ClinicalTrials.gov