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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01239888




Registration number
NCT01239888
Ethics application status
Date submitted
9/11/2010
Date registered
15/11/2010
Date last updated
18/01/2012

Titles & IDs
Public title
Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study
Scientific title
Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression
Secondary ID [1] 0 0
MAPRC 2010CK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxytocin
Treatment: Drugs - Oxytocin and Tibolone
Treatment: Drugs - Placebo

Active Comparator: Oxytocin -

Active Comparator: Oxytocin and Tibolone -

Placebo Comparator: Placebo -


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

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

Treatment: Drugs: Placebo
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Secondary outcome [1] 0 0
Change from baseline in Hamilton Rating Scale for Depression (HAM-D)
Timepoint [1] 0 0
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Secondary outcome [2] 0 0
Change from baseline in Beck Depression Inventory II (BDI-II)
Timepoint [2] 0 0
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Secondary outcome [3] 0 0
Change from baseline in State Trait Anxiety Inventory (STAI)
Timepoint [3] 0 0
Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Secondary outcome [4] 0 0
Adverse Symptom Check List
Timepoint [4] 0 0
baseline, week 2, week 4, week 8
Secondary outcome [5] 0 0
Perceived stress scale
Timepoint [5] 0 0
baseline, week 2, week 4, week 8
Secondary outcome [6] 0 0
Pittsburgh sleep quality index
Timepoint [6] 0 0
baseline, week 2, week 4, week 8
Secondary outcome [7] 0 0
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Timepoint [7] 0 0
baseline, week 2, week 4, week 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01239888
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charlotte Keating, PhD
Address 0 0
Monash University and the Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Charlotte Keating, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 5180
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01239888