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

The Alfred1 site in 1 country15 target enrollmentJanuary 2012

ConditionsDepression Major Depressive Disorder

InterventionsOxytocin Oxytocin and Tibolone Placebo

DrugsOxytocin Oxytocin and Tibolone Placebo

Overview

Phase: Phase 1
Intervention: Oxytocin
Conditions: Depression
Sponsor: The Alfred
Enrollment: 15
Locations: 1
Primary Endpoint: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

November 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The Alfred

Responsible Party

Principal Investigator

Charlotte Keating

Research Fellow

The Alfred

Eligibility Criteria

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

•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)

Arms & Interventions

Oxytocin

Intervention: Oxytocin

Oxytocin and Tibolone

Intervention: Oxytocin and Tibolone

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)
Pittsburgh sleep quality index(baseline, week 2, week 4, week 8)
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(baseline, week 2, week 4, week 8)