Major Depressive DisorderPhase 1/2KODIACNCT04471818
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
A Phase 1/2 study testing Ketamine in people with Major Depressive Disorder and Advanced Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Advanced Cancer
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteMexico
- Study dates
- 19 Sep 2019to 30 Jul 2023
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years of age
- Sex: Male or female
- Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Palliative stage cancer diagnosis (advanced-disease stage)
- Who can read and write in spanish
- Eastern Cooperative Oncology Group (ECOG) 0-2
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- Karnofsky ≥ 50
- Palliative prognostic index A
- Not currently undergoing systemic oncologic treatment
- Patients who agree to participate in the study by signing an informed consent.
Who cannot join
- Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
- Magnetic resonance or computerized tomography with major structural alterations.
- Pregnant or breastfeeding women.
- Patients with hypersensitivity to ketamine
- Cardiac insufficiency
- Patients with a history of psychosis
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- Patients with first-degree relatives with a history of psychosis
- Patients with uncontrolled glaucoma
- Current neurological illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).
MD is a frequent complication in patients who are diagnosed with advanced cancer.
- Conditions
- Major Depressive Disorder, Advanced Cancer
- Being tested
- Ketamine, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
PlaceboOther
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Edinburg Depression Scale (BEDS) score
Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start19 Sep 2019
- Primary completion1 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Raúl Rodríguez Mayoral, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471818
- Sponsor's protocol ID
- (019/024/CPI) /CEI/1332/18)
- Acronym
- KODIAC
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
- ClinicalTrials.gov ID
- NCT04471818
- Acronym / sponsor ID
- KODIAC / (019/024/CPI) /CEI/1332/18)
- Conditions
- Major Depressive Disorder, Advanced Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 15 Jul 2020 (actual)
- 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.
Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).
MD is a frequent complication in patients who are diagnosed with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetaminePatients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPatients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 65 years of age
- Sex: Male or female
- Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Palliative stage cancer diagnosis (advanced-disease stage)
- Who can read and write in spanish
Key exclusion criteria (9 listed)
- Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
- Magnetic resonance or computerized tomography with major structural alterations.
- Pregnant or breastfeeding women.
- Patients with hypersensitivity to ketamine
- Cardiac insufficiency
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 |
|---|---|---|
| KetamineKetamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study | Drug | Ketamine |
| PlaceboPlacebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study | Other | Placebo |
Primary outcome
Brief Edinburg Depression Scale (BEDS) score
Time frame: 3 weeks
Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.
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 28 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine in people with Major Depressive Disorder and Advanced Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 Mexico. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Brief Edinburg Depression Scale (BEDS) score (time frame: 3 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 28 Sep 2023.