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

NCT01239888 | Unknown Phase 1

• 1 other identifier: MAPRC 2010CK
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

  Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks

Secondary Outcomes (7)

• Change from baseline in Hamilton Rating Scale for Depression (HAM-D)

  Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks

• Change from baseline in Beck Depression Inventory II (BDI-II)

  Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks

• Change from baseline in State Trait Anxiety Inventory (STAI)

  Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks

• Adverse Symptom Check List

  baseline, week 2, week 4, week 8

• Perceived stress scale

  baseline, week 2, week 4, week 8

Study Arms (3)

Oxytocin

ACTIVE COMPARATOR

Drug: Oxytocin

Oxytocin and Tibolone

ACTIVE COMPARATOR

Drug: Oxytocin and Tibolone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin DRUG

20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial

Oxytocin

Oxytocin and Tibolone DRUG

20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial

Also known as: Livial (tibolone)

Oxytocin and Tibolone

Placebo DRUG

20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Monash University: collaborator

Study Sites (1)

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Mental Disorders

Interventions

Oxytocin; tibolone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Charlotte Keating, PhD

  Monash University and the Alfred

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Keating, PhD

CONTACT

+61 3 9076 5180; charlotte.keating@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 15, 2010
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

AU (1)