Unipolar DepressionPhase 1NCT02401139
Ketamine Trial for the Treatment of Depression
A Phase 1 study testing Ketamine in people with Unipolar Depression, run by The University of New South Wales at 2 sites in Australia.
Trial summary
This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- Mar 2015to Sep 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Individuals will be eligible for enrolment on the basis of:
- major depressive disorder for at least three months duration
- an inadequate response to at least 2 adequate antidepressants
- MADRS ≥ 20
Patients will be excluded on the basis of:
- History of psychosis
- History of bipolar disorder
- Any unstable medical or neurologic condition
- Any Axis I disorder other than MDD judged to be primary presenting problem
- Planned major changes to psychotropic medication
- Significant risk of suicide
- Planned or probable use of ECT
- Age under 16 years, or 16-17 years without parental consent
- Substance abuse or dependence in previous 6 months
- Any history of abuse of ketamine or phencyclidine
- Contraindication to the use of ketamine
- Planned use of ketamine
- Women of childbearing potential not taking reliable contraception
- Likely non-compliance with trial treatment
- Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Brain & Mind Research Institute (BMRI), University of Sydney
Camperdown, New South Wales, 2050
Black Dog Institute, University of New South Wales
Sydney, New South Wales, 2031
About this study
Official title: Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.
- Conditions
- Unipolar Depression
- Being tested
- Ketamine, Placebo
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | Ketamine Receives: Drug: Ketamine |
| Placebo arm | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen K Loo, MBBS, MD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401139
- Sponsor's protocol ID
- HREC 15009
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
- ClinicalTrials.gov ID
- NCT02401139
- Acronym / sponsor ID
- HREC 15009
- Conditions
- Unipolar Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Mar 2015 (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.
This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: KetamineKetamine |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Ketamine | Drug | Treatment arm |
| Placebo | Drug | Placebo arm |
Primary outcome
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Colleen K Loo, MBBS, MD principal investigator
University of New South Wales
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Unipolar Depression, run by The University of New South Wales at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale for Depression (MADRS) (time frame: 4 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 30 Mar 2023.