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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01239888
• Other study ID #: MAPRC 2010CK
• Status: Recruiting
• Phase: Phase 1
• First received: November 9, 2010
• Last updated: January 15, 2012
• Start date: January 2012

Study information

• Verified date: January 2012
• Source: The Alfred
• Contact: Charlotte Keating, PhD
• Phone: +61 3 9076 5180
• Email: charlotte.keating[@]monash.edu
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Drug:
• Oxytocin
20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
• Oxytocin and Tibolone
20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial
• Placebo
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial

Locations

Country	Name	City	State
Australia	Monash Alfred Psychiatry Research Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The Alfred	Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)		Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks	No
Secondary	Change from baseline in Hamilton Rating Scale for Depression (HAM-D)		Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks	No
Secondary	Change from baseline in Beck Depression Inventory II (BDI-II)		Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks	No
Secondary	Change from baseline in State Trait Anxiety Inventory (STAI)		Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks	No
Secondary	Adverse Symptom Check List		baseline, week 2, week 4, week 8	No
Secondary	Perceived stress scale		baseline, week 2, week 4, week 8	No
Secondary	Pittsburgh sleep quality index		baseline, week 2, week 4, week 8	No
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)		baseline, week 2, week 4, week 8	No