Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study
NCT ID: NCT01239888
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
15 participants
INTERVENTIONAL
2012-01-31
Brief Summary
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Detailed Description
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A secondary objective is the evaluation of neurobiological factors contributing to drug efficacy in treatment resistant depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oxytocin
Oxytocin
20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Oxytocin and Tibolone
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
Placebo
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Monash University
OTHER
The Alfred
OTHER
Responsible Party
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Charlotte Keating
Research Fellow
Principal Investigators
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Charlotte Keating, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University and the Alfred
Locations
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Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAPRC 2010CK
Identifier Type: -
Identifier Source: org_study_id
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