Bipolar DisorderNCT05209217
Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder
An observational study of Bipolar Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
Aim 1: Test the hypothesis that participants with Bipolar Disorder - Fear of Harm Phenotype have an enhanced amygdala fMRI response to fearful threatening stimuli, increased resting beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from… Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Ketamine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 15 Jan 2023
- Phase
- Observational
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Total sample size will be 20 subjects, with approximately equal number of males and females. Subjects recruited for the study will be between 14-40-years-of-age who meet DSM-5 criteria for Bipolar Disorder, Papolos criteria for FOH Phenotype, have been taking intranasal ketamine for at least two months
Who may be able to join
- Males and Females
- Age 14 - 40 years
- Clinical diagnosis of Bipolar Disorder -Fear of Harm Phenotype
- Meets Papolos criteria for FOH based on independent interviews.
- Taking intranasal ketamine for at least 2 months.
- Must be on an every three or every four-day dosing regimen
Show all 11Show fewer
- Dosage will not exceed 300 mg per dosing interval.
- Willing to delay ketamine dose by 2 days past their prescribed dosing interval
- Prior experience having tolerated this degree of delay.
- Willing to participate in daily assessments during period of ketamine withdrawal prior to traveling to Belmont ,MA.
- Willing to provide urine sample to screen for drugs of abuse (all participants and pregnancy in females.)
Who cannot join
- Any psychiatric hospitalization within the past 6 months
- Lifetime history of suicide attempts
- Co-occurring substance use disorders
- Any change in concomitant medications within the last 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Elizabeth Bolger, MA, 617-855-2964, lbolger@mclean.harvard.edu
Martin H Teicher, MD, PHD
About this study
Official title: Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder - Fear of Harm Phenotype
Aim 1: Test the hypothesis that participants with Bipolar Disorder - Fear of Harm Phenotype have an enhanced amygdala fMRI response to fearful threatening stimuli, increased resting beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.
Aim 2. Test the hypothesis that ketamine alters response to fearful-threatening visual stimuli and cold sensation by altering functional connectivity of the amygdala and insula with the hypothalamus, thalamus, hippocampus and ventromedial prefrontal cortex, and identify specific alterations that correlate with degree of pre-post ketamine change.
Aim 3. Test the hypothesis that low-dose medicinal ketamine, unlike high-dose recreation ketamine, is not associated with an increase in number of focal areas of abnormality on morphometric scans based on duration of use.
Read the detailed description
Clinically, the Fear of Harm phenotype is characterized by early age of onset, severe mood swings, treatment resistance, separation anxiety, fearful-aggressive obsessions, parasomnias (e.g. night-terrors) and thermal dysregulation (Papolos et al. 2009). These youth typically received little benefit from standard treatments (i.e., antipsychotic medication and mood stabilizers) often wind up home-schooled due to excessive fears of the school environment and frequently require multiple periods of inpatient care (Papolos et al. 2009; Papolos et al. 2013). Key features seen in FOH that distinguish these youths from other youths with BD include fear sensitization and thermal dysregulation. Children with FOH often experience thermal discomfort (e.g., feeling hot, excessive sweating) in neutral ambient temperature conditions, as well as no discomfort during exposure to the cold, and alternate noticeably between being excessively hot in the evening and cold in the morning (Murphy, Frei, and Papolos 2014). Ketamine, an NMDA receptor antagonist was selected as a potential treatment for FOH because of its effectiveness in the reduction of fear sensitization and capacity to dose-dependently lower body temperature in animal studies, and has been found to be clinically efficacious in the treatment of FOH (Papolos et al. 2018; Papolos et al. 2013). There are two main reasons for proposing to conduct a neuroimaging study. First, intranasal ketamine can produce an almost immediate improvement in clinical state. This makes it possible to scan a subject whose dose of ketamine has largely worn off in order to assess blood flow and functional connectivity and then to rescan the individual within hours of receiving intranasal ketamine in order to correlate degree of clinical improvement with alterations in blood flow and connectivity. This will provide information on both the neurobiological basis of ketamine response and information on the possible biological underpinnings of FOH. Second, there is some concern, based on a report of examining brain scans in chronic ketamine abusers, that ketamine in daily doses 10X higher than clinically prescribed every 3-4 days can produce some evidence for structural brain damage4. Hence, it would be valuable to scan individuals undergoing long term treatment with intranasal ketamine to rule out or monitor for pathological changes in brain structure.
- Conditions
- Bipolar Disorder
- Being tested
- Ketamine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Intranasal administration of their customary prescribed dose
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Participants will all have history of good to excellent clinical response to intranasal ketamine for at least two months and on a treatment schedule varying from use every other day to every fifth day. Participants will be tested one or two days beyond their customary administration date and again 2-3 hours after their administration of ketamine. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD fMRI response in amygdala
Change in BOLD measured by functional Magnetic Resonance Imaging (fMRI) to images of threatening versus neutral facial expressions.
Measured: Prior to and 2-3 hours following ketamine administration
BOLD fMRI response in posterior insula
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and degree of cold stimulation of non-dominant hand.
Measured: Prior to and 2-3 hours following ketamine administration
Secondary outcomes (3)
Functional connectivity between amygdala and insula
Seed-to-seed and seed-to-voxel functional connectivity analysis of rs-fMRI data.
Measured: Prior to and 2-3 hours following ketamine administration
EEG spectral activity measures
Absolute and relative power in low beta (15-26), high beta (28-40), low gamma (42-53) and high gamma (55-67) frequency bands using 32-channel Electrical Geodesics, Inc. EEG.
Measured: Prior to and 2-3 hours following ketamine administration
Profile of Mood State (POMS) scale.
Ratings of tension and total mood score on the POMS.
Measured: Prior to and 2-3 hours following ketamine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start4 Jun 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Bipolar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Bipolar Research Foundation
- Responsible party
- Principal investigator, Martin H Teicher, Mclean Hospital
- Investigators
- Martin H Teicher, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209217
- Sponsor's protocol ID
- 2017P001822
- Status last verified
- Jan 2022
- First submitted
- 26 Oct 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share with other researchers
Publications
Alsop DC, Detre JA, Golay X, Gunther M, Hendrikse J, Hernandez-Garcia L, Lu H, MacIntosh BJ, Parkes LM, Smits M, van Osch MJ, Wang DJ, Wong EC, Zaharchuk G. Recommended implementation of arterial spin-labeled perfusion MRI for clinical applications: A consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. Magn Reson Med. 2015 Jan;73(1):102-16. doi: 10.1002/mrm.25197. Epub 2014 Apr 8.
PubMed 24715426Anderson IM, Juhasz G, Thomas E, Downey D, McKie S, Deakin JF, Elliott R. The effect of acute citalopram on face emotion processing in remitted depression: a pharmacoMRI study. Eur Neuropsychopharmacol. 2011 Jan;21(1):140-8. doi: 10.1016/j.euroneuro.2010.06.008.
PubMed 20599362Castellanos FX, Margulies DS, Kelly C, Uddin LQ, Ghaffari M, Kirsch A, Shaw D, Shehzad Z, Di Martino A, Biswal B, Sonuga-Barke EJ, Rotrosen J, Adler LA, Milham MP. Cingulate-precuneus interactions: a new locus of dysfunction in adult attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 Feb 1;63(3):332-7. doi: 10.1016/j.biopsych.2007.06.025. Epub 2007 Sep 21.
PubMed 17888409Craig AD, Bushnell MC. The thermal grill illusion: unmasking the burn of cold pain. Science. 1994 Jul 8;265(5169):252-5. doi: 10.1126/science.8023144.
PubMed 8023144Craig AD, Chen K, Bandy D, Reiman EM. Thermosensory activation of insular cortex. Nat Neurosci. 2000 Feb;3(2):184-90. doi: 10.1038/72131.
PubMed 10649575Craig AD, Reiman EM, Evans A, Bushnell MC. Functional imaging of an illusion of pain. Nature. 1996 Nov 21;384(6606):258-60. doi: 10.1038/384258a0.
PubMed 8918874Ding X, Ding J, Hua B, Xiong X, Xiao L, Peng F, Chen L, Pan X, Wang Q. Abnormal cortical functional activity in patients with ischemic white matter lesions: A resting-state functional magnetic resonance imaging study. Neurosci Lett. 2017 Mar 22;644:10-17. doi: 10.1016/j.neulet.2017.02.015. Epub 2017 Feb 9.
PubMed 28189742Fahim I, Ismail M, Osman OH. Role of 5-hydroxytryptamine in ketamine-induced hypothermia in the rat. Br J Pharmacol. 1973 Aug;48(4):570-6. doi: 10.1111/j.1476-5381.1973.tb08243.x.
PubMed 4274691Frankenstein UN, Richter W, McIntyre MC, Remy F. Distraction modulates anterior cingulate gyrus activations during the cold pressor test. Neuroimage. 2001 Oct;14(4):827-36. doi: 10.1006/nimg.2001.0883.
PubMed 11554801Heuchert, J. P., & McNair, D. M. (2012). Profile of Mood States, 2nd Edition (POMS-2). North Tonawanda, NY: Multi-Health Systems.
Jenkinson M, Bannister P, Brady M, Smith S. Improved optimization for the robust and accurate linear registration and motion correction of brain images. Neuroimage. 2002 Oct;17(2):825-41. doi: 10.1016/s1053-8119(02)91132-8.
PubMed 12377157Kaufman, J., Birmaher, B., Axelson, D., Perepletchikova, F., Brent, D., & Ryan, N. (2016). Schedule for Affective Disorders and Schizophrenia for School Aged Children (6-18 Years). Kiddie-SADS - Lifetime Version (K-SADS-PL DSM-5 November 2016)
La Cesa S, Tinelli E, Toschi N, Di Stefano G, Collorone S, Aceti A, Francia A, Cruccu G, Truini A, Caramia F. fMRI pain activation in the periaqueductal gray in healthy volunteers during the cold pressor test. Magn Reson Imaging. 2014 Apr;32(3):236-40. doi: 10.1016/j.mri.2013.12.003. Epub 2013 Dec 19.
PubMed 24468081Lapotka M, Ruz M, Salamanca Ballesteros A, Ocon Hernandez O. Cold pressor gel test: A safe alternative to the cold pressor test in fMRI. Magn Reson Med. 2017 Oct;78(4):1464-1468. doi: 10.1002/mrm.26529. Epub 2016 Oct 25.
PubMed 27779778Margulies DS, Kelly AM, Uddin LQ, Biswal BB, Castellanos FX, Milham MP. Mapping the functional connectivity of anterior cingulate cortex. Neuroimage. 2007 Aug 15;37(2):579-88. doi: 10.1016/j.neuroimage.2007.05.019. Epub 2007 May 24.
PubMed 17604651
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study of the Neurobiological Effects of Intranasal Ketamine in Children and Adults With Bipolar Disorder - Fear of Harm Phenotype
- ClinicalTrials.gov ID
- NCT05209217
- Acronym / sponsor ID
- 2017P001822
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Juvenile Bipolar Research Foundation
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 26 Jan 2022 (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.
Aim 1: Test the hypothesis that participants with Bipolar Disorder - Fear of Harm Phenotype have an enhanced amygdala fMRI response to fearful threatening stimuli, increased resting beta and gamma EEG spectral activity in temporal leads and blunted posterior insula response to cold when partially withdrawn from ketamine with normalization of these responses following intranasal administration of ketamine.
Aim 2. Test the hypothesis that ketamine alters response to fearful-threatening visual stimuli and cold sensation by altering functional connectivity of the amygdala and insula with the hypothalamus, thalamus, hippocampus and ventromedial prefrontal cortex, and identify specific alterations that correlate with degree of pre-post ketamine change.
Aim 3. Test the hypothesis that low-dose medicinal ketamine, unlike high-dose recreation ketamine, is not associated with an increase in number of focal areas of abnormality on morphometric scans based on duration of use.
Detailed description
Clinically, the Fear of Harm phenotype is characterized by early age of onset, severe mood swings, treatment resistance, separation anxiety, fearful-aggressive obsessions, parasomnias (e.g. night-terrors) and thermal dysregulation (Papolos et al. 2009). These youth typically received little benefit from standard treatments (i.e., antipsychotic medication and mood stabilizers) often wind up home-schooled due to excessive fears of the school environment and frequently require multiple periods of inpatient care (Papolos et al. 2009; Papolos et al. 2013). Key features seen in FOH that distinguish these youths from other youths with BD include fear sensitization and thermal dysregulation. Children with FOH often experience thermal discomfort (e.g., feeling hot, excessive sweating) in neutral ambient temperature conditions, as well as no discomfort during exposure to the cold, and alternate noticeably between being excessively hot in the evening and cold in the morning (Murphy, Frei, and Papolos 2014). Ketamine, an NMDA receptor antagonist was selected as a potential treatment for FOH because of its effectiveness in the reduction of fear sensitization and capacity to dose-dependently lower body temperature in animal studies, and has been found to be clinically efficacious in the treatment of FOH (Papolos et al. 2018; Papolos et al. 2013). There are two main reasons for proposing to conduct a neuroimaging study. First, intranasal ketamine can produce an almost immediate improvement in clinical state. This makes it possible to scan a subject whose dose of ketamine has largely worn off in order to assess blood flow and functional connectivity and then to rescan the individual within hours of receiving intranasal ketamine in order to correlate degree of clinical improvement with alterations in blood flow and connectivity. This will provide information on both the neurobiological basis of ketamine response and information on the possible biological underpinnings of FOH. Second, there is some concern, based on a report of examining brain scans in chronic ketamine abusers, that ketamine in daily doses 10X higher than clinically prescribed every 3-4 days can produce some evidence for structural brain damage4. Hence, it would be valuable to scan individuals undergoing long term treatment with intranasal ketamine to rule out or monitor for pathological changes in brain structure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | – | Drug: KetamineParticipants will all have history of good to excellent clinical response to intranasal ketamine for at least two months and on a treatment schedule varying from use every other day to every fifth day. Participants will be tested one or two days beyond their customary administration date and again 2-3 hours after their administration of ketamine. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Total sample size will be 20 subjects, with approximately equal number of males and females. Subjects recruited for the study will be between 14-40-years-of-age who meet DSM-5 criteria for Bipolar Disorder, Papolos criteria for FOH Phenotype, have been taking intranasal ketamine for at least two months
Key inclusion criteria (11 listed)
- Males and Females
- Age 14 - 40 years
- Clinical diagnosis of Bipolar Disorder -Fear of Harm Phenotype
- Meets Papolos criteria for FOH based on independent interviews.
- Taking intranasal ketamine for at least 2 months.
Key exclusion criteria (4 listed)
- Any psychiatric hospitalization within the past 6 months
- Lifetime history of suicide attempts
- Co-occurring substance use disorders
- Any change in concomitant medications within the last 2 months
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 |
|---|---|---|
| KetamineIntranasal administration of their customary prescribed dose | Drug | Participant Group |
Primary outcome
BOLD fMRI response in amygdala
Time frame: Prior to and 2-3 hours following ketamine administration
Change in BOLD measured by functional Magnetic Resonance Imaging (fMRI) to images of threatening versus neutral facial expressions.
BOLD fMRI response in posterior insula
Time frame: Prior to and 2-3 hours following ketamine administration
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and degree of cold stimulation of non-dominant hand.
3 secondary outcomes
Functional connectivity between amygdala and insula
Time frame: Prior to and 2-3 hours following ketamine administration
EEG spectral activity measures
Time frame: Prior to and 2-3 hours following ketamine administration
Profile of Mood State (POMS) scale.
Time frame: Prior to and 2-3 hours following ketamine administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Background: PubMed 24715426Alsop DC, Detre JA, Golay X, Gunther M, Hendrikse J, Hernandez-Garcia L, Lu H, MacIntosh BJ, Parkes LM, Smits M, van Osch MJ, Wang DJ, Wong EC, Zaharchuk G. Recommended implementation of arterial spin-labeled perfusion MRI for clinical applications: A consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. Magn Reson Med. 2015 Jan;73(1):102-16. doi: 10.1002/mrm.25197. Epub 2014 Apr 8.
- Background: PubMed 20599362Anderson IM, Juhasz G, Thomas E, Downey D, McKie S, Deakin JF, Elliott R. The effect of acute citalopram on face emotion processing in remitted depression: a pharmacoMRI study. Eur Neuropsychopharmacol. 2011 Jan;21(1):140-8. doi: 10.1016/j.euroneuro.2010.06.008.
- Background: PubMed 17888409Castellanos FX, Margulies DS, Kelly C, Uddin LQ, Ghaffari M, Kirsch A, Shaw D, Shehzad Z, Di Martino A, Biswal B, Sonuga-Barke EJ, Rotrosen J, Adler LA, Milham MP. Cingulate-precuneus interactions: a new locus of dysfunction in adult attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 Feb 1;63(3):332-7. doi: 10.1016/j.biopsych.2007.06.025. Epub 2007 Sep 21.
- Background: PubMed 8023144Craig AD, Bushnell MC. The thermal grill illusion: unmasking the burn of cold pain. Science. 1994 Jul 8;265(5169):252-5. doi: 10.1126/science.8023144.
- Background: PubMed 10649575Craig AD, Chen K, Bandy D, Reiman EM. Thermosensory activation of insular cortex. Nat Neurosci. 2000 Feb;3(2):184-90. doi: 10.1038/72131.
- Background: PubMed 8918874Craig AD, Reiman EM, Evans A, Bushnell MC. Functional imaging of an illusion of pain. Nature. 1996 Nov 21;384(6606):258-60. doi: 10.1038/384258a0.
- Background: PubMed 28189742Ding X, Ding J, Hua B, Xiong X, Xiao L, Peng F, Chen L, Pan X, Wang Q. Abnormal cortical functional activity in patients with ischemic white matter lesions: A resting-state functional magnetic resonance imaging study. Neurosci Lett. 2017 Mar 22;644:10-17. doi: 10.1016/j.neulet.2017.02.015. Epub 2017 Feb 9.
- Background: PubMed 4274691Fahim I, Ismail M, Osman OH. Role of 5-hydroxytryptamine in ketamine-induced hypothermia in the rat. Br J Pharmacol. 1973 Aug;48(4):570-6. doi: 10.1111/j.1476-5381.1973.tb08243.x.
- Background: PubMed 11554801Frankenstein UN, Richter W, McIntyre MC, Remy F. Distraction modulates anterior cingulate gyrus activations during the cold pressor test. Neuroimage. 2001 Oct;14(4):827-36. doi: 10.1006/nimg.2001.0883.
- BackgroundHeuchert, J. P., & McNair, D. M. (2012). Profile of Mood States, 2nd Edition (POMS-2). North Tonawanda, NY: Multi-Health Systems.
- Background: PubMed 12377157Jenkinson M, Bannister P, Brady M, Smith S. Improved optimization for the robust and accurate linear registration and motion correction of brain images. Neuroimage. 2002 Oct;17(2):825-41. doi: 10.1016/s1053-8119(02)91132-8.
- BackgroundKaufman, J., Birmaher, B., Axelson, D., Perepletchikova, F., Brent, D., & Ryan, N. (2016). Schedule for Affective Disorders and Schizophrenia for School Aged Children (6-18 Years). Kiddie-SADS - Lifetime Version (K-SADS-PL DSM-5 November 2016)
- Individual participant dataSharing planned: No. There is no plan to share with other researchers
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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.
Martin H Teicher, MD, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Mclean Hospital at 1 site in United States.
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 4 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 27 Jan 2022. 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 United States. 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.
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 Elizabeth A Bolger, MA (617-855-2964, lbolger@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD fMRI response in amygdala (time frame: Prior to and 2-3 hours following ketamine administration). 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?
On the ClinicalTrials.gov record for NCT05209217, which also lists 30 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 27 Jan 2022.