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

Overview

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.

Full Title of Study: “Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2012

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

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Oxytocin
  • Active Comparator: Oxytocin and Tibolone
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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

Secondary 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
  • 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
  • Change from baseline in State Trait Anxiety Inventory (STAI)
    • Time Frame: 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
  • Perceived stress scale
    • Time Frame: baseline, week 2, week 4, week 8
  • Pittsburgh sleep quality index
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Alfred
  • Collaborator
    • Monash University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Charlotte Keating, Research Fellow – The Alfred
  • Overall Official(s)
    • Charlotte Keating, PhD, Principal Investigator, Monash University and the Alfred
  • Overall Contact(s)
    • Charlotte Keating, PhD, +61 3 9076 5180, charlotte.keating@monash.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.