DepressionPhase 1NCT01239888
Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study
A Phase 1 study testing Oxytocin and Oxytocin and Tibolone in people with Depression and Major Depressive Disorder, run by The Alfred at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Oxytocin and Oxytocin and Tibolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004
Charlotte Keating, PhD, charlotte.keating@monash.edu
Charlotte Keating, PhD
About this study
Official title: Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression
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.
Read the 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.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- Oxytocin, Oxytocin and Tibolone, Placebo
- 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
- Medical subject headings
- Depression, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
Oxytocin and TiboloneDrug
Also called Livial (tibolone)
20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial
PlaceboDrug
20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Not described Receives: Drug: Oxytocin |
| Oxytocin and Tibolone | Active comparator | Not described Receives: Drug: Oxytocin and Tibolone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 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)
Measured: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in Beck Depression Inventory II (BDI-II)
Measured: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in State Trait Anxiety Inventory (STAI)
Measured: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Adverse Symptom Check List
Measured: baseline, week 2, week 4, week 8
Perceived stress scale
Measured: baseline, week 2, week 4, week 8
Pittsburgh sleep quality index
Measured: baseline, week 2, week 4, week 8
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Measured: baseline, week 2, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2012
- Primary completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Charlotte Keating, The Alfred
- Investigators
- Charlotte Keating, PhD, Principal investigator, Monash University and the Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239888
- Sponsor's protocol ID
- MAPRC 2010CK
- Status last verified
- Jan 2012
- First submitted
- 9 Nov 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Study of Efficacy and Safety of Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT01239888
- Acronym / sponsor ID
- MAPRC 2010CK
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- Depression, Treatment resistant depression, Oxytocin, Estrogen Modulators, HPA axis, Mental Disorders, Estrogens, Tibolone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (estimated)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocin |
| Oxytocin and Tibolone | Active comparator | Drug: Oxytocin and Tibolone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial | Drug | Oxytocin |
| Oxytocin and TiboloneAlso: Livial (tibolone)20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial | Drug | Oxytocin and Tibolone |
| Placebo20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Change from baseline in Hamilton Rating Scale for Depression (HAM-D)
Time frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in Beck Depression Inventory II (BDI-II)
Time frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Change from baseline in State Trait Anxiety Inventory (STAI)
Time frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks
Adverse Symptom Check List
Time frame: baseline, week 2, week 4, week 8
Perceived stress scale
Time frame: baseline, week 2, week 4, week 8
Pittsburgh sleep quality index
Time frame: baseline, week 2, week 4, week 8
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time frame: baseline, week 2, week 4, week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Keating, PhD principal investigator
Monash University and the Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin and Oxytocin and Tibolone in people with Depression and Major Depressive Disorder, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Keating, PhD (+61 3 9076 5180 ext. 5180, charlotte.keating@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.