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Depressive Disorder, Treatment-ResistantPhase 4NCT02610712

Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

A Phase 4 study testing Ketamine in people with Depressive Disorder, Treatment-Resistant, run by National Institute of Neurology and Neurosurgery, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Disorder, Treatment-Resistant
What is being tested?
Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteMexico
Study dates
May 2014to Dec 2017
Phase
Phase 4
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

  • Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
  • Acceptance of participation via the informed consent

Who cannot join

  • Psychiatric comorbidity (except anxiety related disorders)
  • Substance abuse or dependence in the previous 3 months
  • Evidence of structural abnormalities in brain imaging
  • Pregnancy
  • Previous hypersensitivity to ketamine
  • Heart failure or insufficiency
Show all 12Show fewer
  • Familial or personal history of psychosis
  • Glaucoma
  • Major neurological disease
  • Uncontrolled systemic arterial hypertension
  • MRI contraindications
  • Non-acceptance of participation via informed consent

Trial locations and contacts

1 site in 1 country.

Rodrigo Pérez-Esparza, MD contact

56063822 ext. 1034

dr.rodrigope@gmail.com

Jesús Ramírez-Bermúdez, MD, MSc contact

56063822 ext. 1034

jesusramirezb@yahoo.com.mx

Mexico1 site, 1 recruiting

  • National Institute of Neurology and Neurosurgery

    Mexico City, Mexico City, 14269

    Rodrigo Pérez-Esparza, MD, 56063822 ext. 1034, dr.rodrigope@gmail.com

    Jesús Ramírez-Bermúdez, MD, MSc, 56063822 ext. 1034, jesusramirezb@yahoo.com.mx

    Recruiting

Other trials in Mexico

About this study

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.

Read the detailed description

The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).

Being tested
Ketamine
Keywords
ketamine, treatment-resistant, depression, spectroscopy, neuroinflammation
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depression, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02610712
Study groupRoleWhat they receive
TRD patientsExperimentalTreatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
Receives: Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale (HDRS) Score

    Measured: Change from baseline HDRS Score at 24 hours

Secondary outcomes (2)

  1. Glutamate concentrations in the pregenual cingulate cortex (pgACC)

    Glutamate concentrations in the pregenual cingulate cortex measured by Magnetic Resonance Spectroscopy

    Measured: Change from baseline Glutamate concentrations in the pgACC at 24 hours

  2. Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations

    Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA

    Measured: Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610712
Sponsor's protocol ID
63/13
Status last verified
Sep 2016
First submitted
17 Nov 2015
Last updated
21 Sep 2016
Results posted
No

Publications

  • Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.

    PubMed 10686270

  • DiazGranados N, Ibrahim LA, Brutsche NE, Ameli R, Henter ID, Luckenbaugh DA, Machado-Vieira R, Zarate CA Jr. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J Clin Psychiatry. 2010 Dec;71(12):1605-11. doi: 10.4088/JCP.09m05327blu. Epub 2010 Jul 13.

    PubMed 20673547

  • Valentine GW, Mason GF, Gomez R, Fasula M, Watzl J, Pittman B, Krystal JH, Sanacora G. The antidepressant effect of ketamine is not associated with changes in occipital amino acid neurotransmitter content as measured by [(1)H]-MRS. Psychiatry Res. 2011 Feb 28;191(2):122-7. doi: 10.1016/j.pscychresns.2010.10.009. Epub 2011 Jan 12.

    PubMed 21232924

  • Zarate CA Jr, Brutsche NE, Ibrahim L, Franco-Chaves J, Diazgranados N, Cravchik A, Selter J, Marquardt CA, Liberty V, Luckenbaugh DA. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry. 2012 Jun 1;71(11):939-46. doi: 10.1016/j.biopsych.2011.12.010. Epub 2012 Jan 31.

    PubMed 22297150

  • Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.

    PubMed 16894061

  • Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.

    PubMed 20679587

  • Horn DI, Yu C, Steiner J, Buchmann J, Kaufmann J, Osoba A, Eckert U, Zierhut KC, Schiltz K, He H, Biswal B, Bogerts B, Walter M. Glutamatergic and resting-state functional connectivity correlates of severity in major depression - the role of pregenual anterior cingulate cortex and anterior insula. Front Syst Neurosci. 2010 Jul 15;4:33. doi: 10.3389/fnsys.2010.00033. eCollection 2010.

    PubMed 20700385

  • Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.

    PubMed 23982301

  • Musazzi L, Treccani G, Mallei A, Popoli M. The action of antidepressants on the glutamate system: regulation of glutamate release and glutamate receptors. Biol Psychiatry. 2013 Jun 15;73(12):1180-8. doi: 10.1016/j.biopsych.2012.11.009. Epub 2012 Dec 28.

    PubMed 23273725

  • Luykx JJ, Laban KG, van den Heuvel MP, Boks MP, Mandl RC, Kahn RS, Bakker SC. Region and state specific glutamate downregulation in major depressive disorder: a meta-analysis of (1)H-MRS findings. Neurosci Biobehav Rev. 2012 Jan;36(1):198-205. doi: 10.1016/j.neubiorev.2011.05.014. Epub 2011 Jun 6.

    PubMed 21672551

  • Stone JM, Dietrich C, Edden R, Mehta MA, De Simoni S, Reed LJ, Krystal JH, Nutt D, Barker GJ. Ketamine effects on brain GABA and glutamate levels with 1H-MRS: relationship to ketamine-induced psychopathology. Mol Psychiatry. 2012 Jul;17(7):664-5. doi: 10.1038/mp.2011.171. Epub 2012 Jan 3. No abstract available.

    PubMed 22212598

  • Miller AH, Maletic V, Raison CL. Inflammation and its discontents: the role of cytokines in the pathophysiology of major depression. Biol Psychiatry. 2009 May 1;65(9):732-41. doi: 10.1016/j.biopsych.2008.11.029. Epub 2009 Jan 15.

    PubMed 19150053

  • Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.

    PubMed 20015486

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine in people with Depressive Disorder, Treatment-Resistant, run by National Institute of Neurology and Neurosurgery, 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 2 inclusion and 12 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 21 Sep 2016. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Rodrigo Pérez-Esparza, MD (56063822 ext. 1034, dr.rodrigope@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HDRS) Score (time frame: Change from baseline HDRS Score at 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02610712, which also lists 13 linked publications.

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 21 Sep 2016.

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