Depressive Disorder,Phase 2NCT01868802
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
A Phase 2 study testing Ketamine in people with Depressive Disorder, and Treatment-Resistant Depression, run by Paul J. Lamothe at 1 site in Mexico.
Trial summary
A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder,, Treatment-Resistant Depression
- 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
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2013to May 2016
- Phase
- Phase 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: 18-65 years old
- Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
- Classification of MDD as treatment-resistant.
- No brain structural abnormalities as evidenced by an MRI scan.
- Signed acceptance of Informed Consent.
Who cannot join
- Other psychiatric diagnosis apart from MDD.
- Substance abuse or dependence (prior or during study).
- Pregnancy.
- Congestive heart disease.
- Personal history of psychosis.
- First-degree relative with history of psychosis.
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- Glaucoma.
- Present neurological disease.
- High blood or pulmonary artery pressure.
- Declining the signing of the informed consent.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
ABC Neurological Center
Mexico City, Mexico City, 05300
Eduardo San Esteban, M.D., +52 (55) 52308000, esanesteban@hotmail.com
Paul J Lamothe Molina, M.D.
About this study
A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
- Being tested
- Ketamine, Placebo
- Keywords
- Ketamine, Depression, Depressive Disorder
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
PlaceboDrug
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine treated | Experimental | Not described Receives: Drug: Ketamine |
| Control, placebo treated | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in baseline HDRS Score
The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.
Measured: 20 minutes before and 40 minutes after ketamine infusion.
Daily change in HDRS post-ketamine infusion.
On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.
Measured: 1,2,3,4,5,6 and 7. Days after ketamine infusion
Secondary outcomes (2)
Baseline blood pressure (BP).
Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
Measured: 20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)
BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.
Measured: every 5 minutes in a 300 minutes period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder,Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul J. Lamothe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul J. Lamothe, American British Cowdray Medical Center
- Investigators
- Paul J Lamothe, M.D., Principal investigator, American British Cowdray Medical CenterDavid N Lopez-Garza, M.D., Study director, American British Cowdray Medical CenterManuel Ruiz-Alvarez, M.D., Principal investigator, American British Cowdray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868802
- Sponsor's protocol ID
- ABC KET-DRT-01-2013
- Status last verified
- Mar 2015
- First submitted
- 24 May 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
- ClinicalTrials.gov ID
- NCT01868802
- Acronym / sponsor ID
- ABC KET-DRT-01-2013
- Keywords
- Ketamine, Depression, Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Paul J. LamotheUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2016 (estimated)
- First posted
- 5 Jun 2013 (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.
A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine treated | Experimental | Drug: Ketamine |
| Control, placebo treated | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 years old
- Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
- Classification of MDD as treatment-resistant.
- No brain structural abnormalities as evidenced by an MRI scan.
- Signed acceptance of Informed Consent.
Key exclusion criteria (10 listed)
- Other psychiatric diagnosis apart from MDD.
- Substance abuse or dependence (prior or during study).
- Pregnancy.
- Congestive heart disease.
- Personal history of psychosis.
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 |
|---|---|---|
| KetamineAlso: KetalarA single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes. | Drug | Ketamine treated |
| PlaceboSaline at 0.9% intravenous infusion will be administered over 40 minutes. | Drug | Control, placebo treated |
Primary outcome
Changes in baseline HDRS Score
Time frame: 20 minutes before and 40 minutes after ketamine infusion.
The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.
Daily change in HDRS post-ketamine infusion.
Time frame: 1,2,3,4,5,6 and 7. Days after ketamine infusion
On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.
2 secondary outcomes
Baseline blood pressure (BP).
Time frame: 20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)
Time frame: every 5 minutes in a 300 minutes period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
Paul J Lamothe, M.D. principal investigator
American British Cowdray Medical Center
David N Lopez-Garza, M.D. study director
American British Cowdray Medical Center
Manuel Ruiz-Alvarez, M.D. principal investigator
American British Cowdray Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine in people with Depressive Disorder, and Treatment-Resistant Depression, run by Paul J. Lamothe 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 5 inclusion and 10 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 17 Mar 2015. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul J Lamothe, M.D. (+52 (55) 11031750, paul@lamothe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in baseline HDRS Score (time frame: 20 minutes before and 40 minutes after ketamine infusion.). The study lists 2 primary outcomes in all. 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 17 Mar 2015.