NMDA Receptor FunctionGuaKetNCT01600885
The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects
A study testing Guanfacine in people with NMDA Receptor Function, run by Yale University at 3 sites in United States.
Trial summary
The purpose of the study is 1. To establish the feasibility of fMRI studies of the interaction of guanfacine and ketamine. 2. To explore the possibility that guanfacine can ameliorate the negative effects of ketamine on task-related prefrontal activation. 3. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NMDA Receptor Function
- What is being tested?
- Guanfacine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 21 and 45, inclusive
- Right-handed
- Have at least a 12th grade education level or equivalent
- Able to read and write English as a primary language
- Willing to refrain from caffeine and alcohol use for one week prior to each MRI session.
Who cannot join
- Abnormality on physical examination
- A 12 lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG
- A positive pre-study urine drug screen or, at the study physicians' discretion on any drug screens given before the scans
- Abnormality on clinical chemistry or hematology examination at the pre-study medical screening.
- History of positive HIV or Hepatitis B.
- Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan.
Show all 24Show fewer
- History of any substance abuse disorder meeting DSM-IV criteria with the exception of nicotine
- Any history of DSM-IV Axis I psychiatric disorders,
- Any history of major medical or neurological disorders
- Any history indicating learning disability, mental retardation, or attention deficit disorder.
- First-degree relative with Axis I DSM-IV disorder including substance abuse or dependence.
- Any clinically significant abnormalities on screening electrocardiogram
- Any history of head injury
- Any evidence of psychosis-like symptoms, as indicated by elevated scores on the Perceptual Aberration-Magical Ideation (Chapman, Chapman et al. 1978; Eckblad, Chapman et al. 1983) and the revised Social Anhedonia scales(Eckblad, Chapman et al. unpublished)
- A positive urine toxicology screen for illicit substance use or positive alcohol breathalyzer test conducted at screening interview and prior to each MRI session
- Known sensitivity to ketamine.
- Body circumference of 52 inches or greater.
- History of claustrophobia
- Any clinically significant impairment of color vision or visual acuity after correction available in the scanner.
- Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI screening questionnaire
- Pregnancy or breast-feeding would exclude potential participants and all female subjects will receive a urine pregnancy test at screening and before each MRI scan.
- Donation of blood in excess of 500 mL within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Blood pressure must be higher than 90/70. Pulse must be greater than 40 unless the participant is cleared by a study physician
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Connecticut Mental Health Center
New Haven, Connecticut, 06511
Yale Magnetic Resonance Research Center
New Haven, Connecticut, 06520
Veterans Affairs Hospital
West Haven, Connecticut, 06516
About this study
The purpose of the study is
- To establish the feasibility of fMRI studies of the interaction of guanfacine and ketamine.
- To explore the possibility that guanfacine can ameliorate the negative effects of ketamine on task-related prefrontal activation.
- To assess the strength of any interaction between guanfacine and ketamine.
Read the detailed description
Potential subjects will be interviewed over the phone and, if appropriate, will be scheduled for a screening session. Participants who meet study criteria will participate in two study sessions separated by at least two weeks. The sessions will be identical except on one day they will receive guanfacine and on the other, they will receive a placebo.
This study was initially completed in 2014. Upon analysis of the collected data, it was decided to add additional subjects and gather additional data to verify results seen in the collected data. The study was reopened and new data was added beginning in September 2016. Information about the study beginning in 2016 is available in a separate record.
- Conditions
- NMDA Receptor Function
- Being tested
- Guanfacine, Placebo
- Keywords
- Guanfacine, Ketamine, Functional Magnetic Resonance Imaging, Prefrontal Cortex Activity, Receptors, N-Methyl-D-Aspartate, Receptors, Adrenergic, alpha-2, Memory, Short-Term, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Subjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
PlaceboDrug
Subjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine then Placebo | Active comparator | During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. Receives: Drug: Guanfacine; Drug: Placebo |
| Placebo then Guanfacine | Active comparator | During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. Receives: Drug: Guanfacine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule
Scans will be analyzed for task-related prefrontal activation
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Measured: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Measured: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Measured: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startAug 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for NMDA Receptor FunctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- John H Krystal, M.D., Principal investigator, Yale UniversityNaomi R Driesen, Ph.D., Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600885
- Sponsor's protocol ID
- 0807004092
- Acronym
- GuaKet
- Status last verified
- Jul 2017
- First submitted
- 15 May 2012
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Arnsten AF, Cai JX. Postsynaptic alpha-2 receptor stimulation improves memory in aged monkeys: indirect effects of yohimbine versus direct effects of clonidine. Neurobiol Aging. 1993 Nov-Dec;14(6):597-603. doi: 10.1016/0197-4580(93)90044-c.
PubMed 7905189Bjarnadottir M, Misner DL, Haverfield-Gross S, Bruun S, Helgason VG, Stefansson H, Sigmundsson A, Firth DR, Nielsen B, Stefansdottir R, Novak TJ, Stefansson K, Gurney ME, Andresson T. Neuregulin1 (NRG1) signaling through Fyn modulates NMDA receptor phosphorylation: differential synaptic function in NRG1+/- knock-outs compared with wild-type mice. J Neurosci. 2007 Apr 25;27(17):4519-29. doi: 10.1523/JNEUROSCI.4314-06.2007.
PubMed 17460065Brandt, J. The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms The Clinical Neuropsychologist 125-142, 1991
Buccafusco JJ. Neuropharmacologic and behavioral actions of clonidine: interactions with central neurotransmitters. Int Rev Neurobiol. 1992;33:55-107. doi: 10.1016/s0074-7742(08)60691-1. No abstract available.
PubMed 1350577Chapman LJ, Chapman JP, Raulin ML. Body-image aberration in Schizophrenia. J Abnorm Psychol. 1978 Aug;87(4):399-407. doi: 10.1037//0021-843x.87.4.399. No abstract available.
PubMed 681612Cho HS, D'Souza DC, Gueorguieva R, Perry EB, Madonick S, Karper LP, Abi-Dargham A, Belger A, Abi-Saab W, Lipschitz D, Bennet A, Seibyl JP, Krystal JH. Absence of behavioral sensitization in healthy human subjects following repeated exposure to ketamine. Psychopharmacology (Berl). 2005 Apr;179(1):136-43. doi: 10.1007/s00213-004-2066-5. Epub 2005 Jan 29.
PubMed 15682309da Silva TL, Pianca TG, Roman T, Hutz MH, Faraone SV, Schmitz M, Rohde LA. Adrenergic alpha2A receptor gene and response to methylphenidate in attention-deficit/hyperactivity disorder-predominantly inattentive type. J Neural Transm (Vienna). 2008;115(2):341-5. doi: 10.1007/s00702-007-0835-0. Epub 2008 Jan 16.
PubMed 18200436Driesen NR, Leung HC, Calhoun VD, Constable RT, Gueorguieva R, Hoffman R, Skudlarski P, Goldman-Rakic PS, Krystal JH. Impairment of working memory maintenance and response in schizophrenia: functional magnetic resonance imaging evidence. Biol Psychiatry. 2008 Dec 15;64(12):1026-34. doi: 10.1016/j.biopsych.2008.07.029. Epub 2008 Sep 27.
PubMed 18823880Eckblad M, Chapman LJ. Magical ideation as an indicator of schizotypy. J Consult Clin Psychol. 1983 Apr;51(2):215-25. doi: 10.1037//0022-006x.51.2.215. No abstract available.
PubMed 6841765Friedman JI, Adler DN, Temporini HD, Kemether E, Harvey PD, White L, Parrella M, Davis KL. Guanfacine treatment of cognitive impairment in schizophrenia. Neuropsychopharmacology. 2001 Sep;25(3):402-9. doi: 10.1016/S0893-133X(01)00249-4.
PubMed 11522468Glantz LA, Lewis DA. Dendritic spine density in schizophrenia and depression. Arch Gen Psychiatry. 2001 Feb;58(2):203. doi: 10.1001/archpsyc.58.2.203. No abstract available.
PubMed 11177126Glantz LA, Lewis DA. Decreased dendritic spine density on prefrontal cortical pyramidal neurons in schizophrenia. Arch Gen Psychiatry. 2000 Jan;57(1):65-73. doi: 10.1001/archpsyc.57.1.65.
PubMed 10632234Hahn CG, Wang HY, Cho DS, Talbot K, Gur RE, Berrettini WH, Bakshi K, Kamins J, Borgmann-Winter KE, Siegel SJ, Gallop RJ, Arnold SE. Altered neuregulin 1-erbB4 signaling contributes to NMDA receptor hypofunction in schizophrenia. Nat Med. 2006 Jul;12(7):824-8. doi: 10.1038/nm1418. Epub 2006 Jun 11.
PubMed 16767099Hunt RD, Arnsten AF, Asbell MD. An open trial of guanfacine in the treatment of attention-deficit hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1995 Jan;34(1):50-4. doi: 10.1097/00004583-199501000-00013.
PubMed 7860456Jakala P, Riekkinen M, Sirvio J, Koivisto E, Kejonen K, Vanhanen M, Riekkinen P Jr. Guanfacine, but not clonidine, improves planning and working memory performance in humans. Neuropsychopharmacology. 1999 May;20(5):460-70. doi: 10.1016/S0893-133X(98)00127-4.
PubMed 10192826
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01600885
- Acronym / sponsor ID
- GuaKet / 0807004092
- Conditions
- NMDA Receptor Function
- Keywords
- Guanfacine, Ketamine, Functional Magnetic Resonance Imaging, Prefrontal Cortex Activity, Receptors, N-Methyl-D-Aspartate, Receptors, Adrenergic, alpha-2, Memory, Short-Term, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Aug 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 28 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is
- To establish the feasibility of fMRI studies of the interaction of guanfacine and ketamine.
- To explore the possibility that guanfacine can ameliorate the negative effects of ketamine on task-related prefrontal activation.
- To assess the strength of any interaction between guanfacine and ketamine.
Detailed description
Potential subjects will be interviewed over the phone and, if appropriate, will be scheduled for a screening session. Participants who meet study criteria will participate in two study sessions separated by at least two weeks. The sessions will be identical except on one day they will receive guanfacine and on the other, they will receive a placebo.
This study was initially completed in 2014. Upon analysis of the collected data, it was decided to add additional subjects and gather additional data to verify results seen in the collected data. The study was reopened and new data was added beginning in September 2016. Information about the study beginning in 2016 is available in a separate record.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine then Placebo | Active comparator | Drug: Guanfacine, Drug: PlaceboDuring the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. |
| Placebo then Guanfacine | Active comparator | Drug: Guanfacine, Drug: PlaceboDuring the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 21 and 45, inclusive
- Right-handed
- Have at least a 12th grade education level or equivalent
- Able to read and write English as a primary language
- Willing to refrain from caffeine and alcohol use for one week prior to each MRI session.
Key exclusion criteria (24 listed)
- Abnormality on physical examination
- A 12 lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG
- A positive pre-study urine drug screen or, at the study physicians' discretion on any drug screens given before the scans
- Abnormality on clinical chemistry or hematology examination at the pre-study medical screening.
- History of positive HIV or Hepatitis B.
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 |
|---|---|---|
| GuanfacineSubjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes. | Drug | Guanfacine then Placebo, Placebo then Guanfacine |
| PlaceboSubjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes. | Drug | Guanfacine then Placebo, Placebo then Guanfacine |
Primary outcome
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Scans will be analyzed for task-related prefrontal activation Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus
Time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion
Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7905189Arnsten AF, Cai JX. Postsynaptic alpha-2 receptor stimulation improves memory in aged monkeys: indirect effects of yohimbine versus direct effects of clonidine. Neurobiol Aging. 1993 Nov-Dec;14(6):597-603. doi: 10.1016/0197-4580(93)90044-c.
- Background: PubMed 17460065Bjarnadottir M, Misner DL, Haverfield-Gross S, Bruun S, Helgason VG, Stefansson H, Sigmundsson A, Firth DR, Nielsen B, Stefansdottir R, Novak TJ, Stefansson K, Gurney ME, Andresson T. Neuregulin1 (NRG1) signaling through Fyn modulates NMDA receptor phosphorylation: differential synaptic function in NRG1+/- knock-outs compared with wild-type mice. J Neurosci. 2007 Apr 25;27(17):4519-29. doi: 10.1523/JNEUROSCI.4314-06.2007.
- BackgroundBrandt, J. The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms The Clinical Neuropsychologist 125-142, 1991
- Background: PubMed 1350577Buccafusco JJ. Neuropharmacologic and behavioral actions of clonidine: interactions with central neurotransmitters. Int Rev Neurobiol. 1992;33:55-107. doi: 10.1016/s0074-7742(08)60691-1. No abstract available.
- Background: PubMed 681612Chapman LJ, Chapman JP, Raulin ML. Body-image aberration in Schizophrenia. J Abnorm Psychol. 1978 Aug;87(4):399-407. doi: 10.1037//0021-843x.87.4.399. No abstract available.
- Background: PubMed 15682309Cho HS, D'Souza DC, Gueorguieva R, Perry EB, Madonick S, Karper LP, Abi-Dargham A, Belger A, Abi-Saab W, Lipschitz D, Bennet A, Seibyl JP, Krystal JH. Absence of behavioral sensitization in healthy human subjects following repeated exposure to ketamine. Psychopharmacology (Berl). 2005 Apr;179(1):136-43. doi: 10.1007/s00213-004-2066-5. Epub 2005 Jan 29.
- Background: PubMed 18200436da Silva TL, Pianca TG, Roman T, Hutz MH, Faraone SV, Schmitz M, Rohde LA. Adrenergic alpha2A receptor gene and response to methylphenidate in attention-deficit/hyperactivity disorder-predominantly inattentive type. J Neural Transm (Vienna). 2008;115(2):341-5. doi: 10.1007/s00702-007-0835-0. Epub 2008 Jan 16.
- Background: PubMed 18823880Driesen NR, Leung HC, Calhoun VD, Constable RT, Gueorguieva R, Hoffman R, Skudlarski P, Goldman-Rakic PS, Krystal JH. Impairment of working memory maintenance and response in schizophrenia: functional magnetic resonance imaging evidence. Biol Psychiatry. 2008 Dec 15;64(12):1026-34. doi: 10.1016/j.biopsych.2008.07.029. Epub 2008 Sep 27.
- Background: PubMed 6841765Eckblad M, Chapman LJ. Magical ideation as an indicator of schizotypy. J Consult Clin Psychol. 1983 Apr;51(2):215-25. doi: 10.1037//0022-006x.51.2.215. No abstract available.
- Background: PubMed 11522468Friedman JI, Adler DN, Temporini HD, Kemether E, Harvey PD, White L, Parrella M, Davis KL. Guanfacine treatment of cognitive impairment in schizophrenia. Neuropsychopharmacology. 2001 Sep;25(3):402-9. doi: 10.1016/S0893-133X(01)00249-4.
- Background: PubMed 11177126Glantz LA, Lewis DA. Dendritic spine density in schizophrenia and depression. Arch Gen Psychiatry. 2001 Feb;58(2):203. doi: 10.1001/archpsyc.58.2.203. No abstract available.
- Background: PubMed 10632234Glantz LA, Lewis DA. Decreased dendritic spine density on prefrontal cortical pyramidal neurons in schizophrenia. Arch Gen Psychiatry. 2000 Jan;57(1):65-73. doi: 10.1001/archpsyc.57.1.65.
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.
John H Krystal, M.D. principal investigator
Yale University
Naomi R Driesen, Ph.D. study director
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guanfacine in people with NMDA Receptor Function, run by Yale University at 3 sites 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 5 inclusion and 24 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 28 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule (time frame: Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion). The study lists 3 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 NCT01600885, which also lists 29 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 Aug 2017.