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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by The Alfred.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
Charlotte Keating, The Alfred
ClinicalTrials.gov Identifier:
NCT01239888
First received: November 9, 2010
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Depression
Major Depressive Disorder
Drug: Oxytocin
Drug: Oxytocin and Tibolone
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in State Trait Anxiety Inventory (STAI) [ Time Frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Adverse Symptom Check List [ Time Frame: baseline, week 2, week 4, week 8 ] [ Designated as safety issue: No ]
  • Perceived stress scale [ Time Frame: baseline, week 2, week 4, week 8 ] [ Designated as safety issue: No ]
  • Pittsburgh sleep quality index [ Time Frame: baseline, week 2, week 4, week 8 ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [ Time Frame: baseline, week 2, week 4, week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Livial (tibolone)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239888

Contacts
Contact: Charlotte Keating, PhD +61 3 9076 5180 ext 5180 charlotte.keating@monash.edu

Locations
Australia, Victoria
Monash Alfred Psychiatry Research Centre Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Charlotte Keating, PhD       charlotte.keating@monash.edu   
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         
Sponsors and Collaborators
The Alfred
Monash University
Investigators
Principal Investigator: Charlotte Keating, PhD Monash University and the Alfred
  More Information

No publications provided

Responsible Party: Charlotte Keating, Research Fellow, The Alfred
ClinicalTrials.gov Identifier: NCT01239888     History of Changes
Other Study ID Numbers: MAPRC 2010CK
Study First Received: November 9, 2010
Last Updated: January 15, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:
Depression
Treatment resistant depression
Oxytocin
Estrogen Modulators
HPA axis
Mental Disorders
Estrogens
Tibolone
Estrogen Receptor Modulators
Androgens
Hormones
Hormone Substitutes
Physiological Effects of Drugs
Pharmacologic Actions
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Estrogen Antagonists
Hormone Antagonists
Tibolone
Oxytocin
Estrogen Receptor Modulators
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Therapeutic Uses
Androgen Antagonists
Antihypertensive Agents
Cardiovascular Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones

ClinicalTrials.gov processed this record on September 11, 2014