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

January 15, 2012 updated by: Charlotte Keating, The Alfred

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Monash Alfred Psychiatry Research Centre
        • Contact:
        • Principal Investigator:
          • Charlotte Keating, PhD
        • Sub-Investigator:
          • Paul Fitzgerald, MBBS, MPM, FRANZCP, PhD
        • Sub-Investigator:
          • Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD
        • Sub-Investigator:
          • Alan Tilbrook, BAgSc(Hons), PhD
        • Sub-Investigator:
          • Anthony DeCastella, DipAppSci, BA, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • 18-45 years
  • Current DSM-IV diagnosis of Major Depression
  • Comorbid anxiety disorders secondary to depression will be included
  • Past history of at least 2 failed treatment responses (including SSRIs) at the highest tolerated dose for at least 4-6 weeks
  • A MADRS score >20 at randomization
  • Women on a stable dose of an SSRI (sertraline, citalopram, escitalopram, paroxetine, fluoxetine or fluvoxamine) for at least 4-6 weeks.
  • A negative pregnancy test at screening
  • A clinically acceptable Pap smear within the past 2 years
  • Must be able to use intranasal spray and swallow tablets

Patients may take up to 2 sleep medications permitted at a dose considered reasonable by the investigating team. Limited adjustments in sleep medication are acceptable. Patients will be asked to notify the researchers of any changes to their sleep medication.

Exclusion Criteria:

  • Any previous history of adverse side-effects to escitalopram (or other SSRI)
  • Use of oral contraceptives (or any hormonal method of contraception) for the duration of the study
  • DSM-IV defined substance dependence, history of bipolar disorder, schizoaffective disorder or schizophrenia
  • Significant unstable medical illness including epilepsy, diabetes or cardiac related, renal or liver disease, hormone dependent cancer or pregnancy
  • A BMI<18 or > 34kg/m2
  • Planning for pregnancy
  • Renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months.
  • An undiagnosed genital bleeding
  • Moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia ( will exclude women with clinically meaningful androgen excess)
  • Active malignancy, or treatment for malignancy in the preceding 6 months (excluding non-melanotic skin cancer)
  • Alcohol consumption in excess of 3 standard drinks per day
  • Lactose intolerance
  • An abnormal thyroid stimulating hormone (TSH) value at screening confirmed by a Free T4 outside the normal laboratory range (patients with an abnormal TSH, normal Free T4 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study).
  • A history of allergic reactions to androgens (oral or patch)
  • Chronic medications: aspirin and warfarin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Active Comparator: Oxytocin
Drug: Oxytocin
20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Active Comparator: Oxytocin and Tibolone
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
Other Names:
  • Livial (tibolone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Hamilton Rating Scale for Depression (HAM-D)
Time Frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in Beck Depression Inventory II (BDI-II)
Time Frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in State Trait Anxiety Inventory (STAI)
Time Frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Adverse Symptom Check List
Time Frame: baseline, week 2, week 4, week 8
baseline, week 2, week 4, week 8
Perceived stress scale
Time Frame: baseline, week 2, week 4, week 8
baseline, week 2, week 4, week 8
Pittsburgh sleep quality index
Time Frame: baseline, week 2, week 4, week 8
baseline, week 2, week 4, week 8
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time Frame: baseline, week 2, week 4, week 8
baseline, week 2, week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Alfred

Collaborators

Monash University

Investigators

  • Principal Investigator: Charlotte Keating, PhD, Monash University and the Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 15, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAPRC 2010CK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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