Obsessive-Compulsive DisorderPhase 1/2NCT02422290
Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
A Phase 1/2 study testing Ketamine in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This pilot study is proposed to determine the acceptability, feasibility and potential efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults with OCD. Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Jul 2020
- Phase
- Phase 1/2
- 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 14 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must be 14-22 years of age at the time of consent (post-pubertal)
- Participant and a parent/guardian must be able to read and understand English
- Participant must be physically healthy and weigh at least 25kg. If female, must not be pregnant.
- Participant must fulfill DSM-V criteria for OCD, OCD being the principal disorder (i.e., currently the most severe and in need of treatment) and have had OCD for at least six months.
- Participant must score ≥ 16 on the Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS) prior to entering the study, report at least moderate severity of obsessions and/or compulsions..
- Participant must have tried and failed at least one adequate trial of SRI medications or clomipramine and a course of CBT unless the participant is unable to access or tolerate CBT treatment.
Show all 11Show fewer
- In order to meet criteria for having had at least one adequate trial of SRI medication, participants must have been on a stable and minimal adequate dose of at least one SRI medication or clomipramine as defined by the literature for at least 12 weeks, and have a documented history of intolerable adverse effects at a higher dose as evaluated by the study psychiatrist and are therefore unable to increase the dose or complete the full 12 weeks, or have refused further SRI trials.
- Congruent with the literature, the range of minimally adequate doses to treat OCD are as follows: Clomipramine (Anafranil) 75-100 mg/day; Fluoxetine (Prozac) 20-60 mg/day; Paroxetine or Paroxetine CR (Paxil) 20-40 mg/day; Sertraline (Zoloft) 50-100 mg/day; Fluvoxamine (Luvox) 100-200 mg/day; Citalopram (Celexa) 20-40 mg; Escitalopram (Lexapro) 10-20 mg/day for a minimum of 12 weeks.
- In order to meet criteria for having had an adequate course of CBT for OCD, patients should have received at least 8 sessions of Exposure and Response Prevention Therapy (EX/RP) by a licensed clinician trained in doing CBT for OCD. A CBT expert on our team will ensure that the clinician administering these exposures has had adequate training and experience in providing this treatment.
- Participant is off all psychotropic and other types of drugs likely to interact with glutamate for at least 14 days before starting the study. The exceptions are SRI medications and short acting benzodiazepines for distressing anxiety or insomnia (which can be taken up to 24 hours prior to ketamine infusion). Participants will be off neuroleptics for 1 month and off fluoxetine for 6 weeks prior to the study.
- For participants younger than 18, written informed assent by the participant and consent by the parent. For participants 19 and older, written consent by the participant and permission for legal guardian/parent to provide information.
Who cannot join
- Family history of psychosis or substance abuse/dependence.
- History of violence
- Presence of psychotic symptoms or lifetime diagnosis of schizophrenia including any auditory or visual hallucinations or presence of delusional thinking, bipolar disorder, substance-induced psychotic disorder, psychosis due to general medical condition.
- Severely depressed patients with the Children's Depression Rating Scale (CDRS) ≥ 60 or judged clinically to be at risk of suicide.
- Current diagnosis of an eating disorder.
- Current or past history of PTSD or significant trauma.
Show all 16Show fewer
- Current or past diagnosis of substance abuse/dependence.
- Current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS). This will be defined by the following criteria: abrupt onset of OCD symptoms (often with comorbid tics) with a relapsing-remitting symptom course, a temporal association between symptom exacerbations and a Group-A beta-hemolytic streptococcal (GAS) infection, association with neurological abnormalities during exacerbations (adventitious movements, motoric hyperactivity, urinary hesitancy), and prepubertal age of onset.
- Participants planning to commence cognitive-behavioral therapy during the period of the study or those who have begun CBT within 8 weeks prior to enrollment.
- Documented history of hypersensitivity or intolerance to ketamine.
- Female participants who are either pregnant or nursing or female participants of child bearing age who are sexually active and not taking hormonal birth control.
- History of significant medical condition that might increase the risk of participation. This would include hypertension (BP > 140/90), chronic congestive heart failure, tachyarrhythmias, myocardial ischemia, intracranial mass lesions, head injury, globe injuries, or hydrocephalus.
- Concurrent use of any medications that might increase the risk of participation. This would include: St. John's Wort, Tramadol or atracurium, due to potential adverse drug-drug interactions.
- Positive urine screen for illicit drugs
- Inability of participant or parent/guardian to read or understand English.
- Documented history of adverse reaction to anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University
New York, New York, 10032
About this study
This pilot study is proposed to determine the acceptability, feasibility and potential efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of the 14-day treatment phase, all participants will be offered three months of open treatment for OCD with medication and/or CBT.
Read the detailed description
See Brief Summary for description.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Ketamine
- Keywords
- Obsessive Compulsive Disorder, Ketamine, Glutamate, OCD treatment, OCD medication
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Single infusion of IV Ketamine, 0.5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and young adults with OCD | Experimental | All participants will be receive the intravenous ketamine infusion. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
The CY-BOCS is a semi-structured measure of OCD severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language. The CY-BOCS consists of 10 items which are summed up to derive the total CY-BOCS score. The total score ranges from 0-40 with higher scores indicating greater severity of OCD symptoms.
Measured: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
Clinical Global Impressions - Severity Scale (CGI-S)
The CGI-S is a clinician rated 7-point rating scale for the severity of a participant's illness relative to the clinician's experience of working with this particular population. The score ranges from 1-7 with higher scores indicating greater illness severity.
Measured: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
Secondary outcomes (2)
OCD Visual Analogue Scale (OCD-VAS)
The OCD-VAS is a one-item unipolar scale to assess OCD symptoms over a rapid time frame ("No obsessions" to "Constant obsessions"). The scale ranges from 0-10 with higher scores indicating higher presence of obsessions.
Measured: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
Yale-Brown Obsessive Compulsive Challenge Scale (Y-BOCCS)
The Y-BOCCS is self-report scale which assesses OCD symptoms on a 5-point likert scale ("None" to "Extreme"). It consists of 10 items which are summed up to derive the total Y-BOCCS score. The total score ranges from 0-40 with higher scores indicating higher prevalence of OCD symptoms.
Measured: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion21 Feb 2018
- Study completion31 Jul 2020
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 (23)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Responsible party
- Principal investigator, Pablo H. Goldberg, New York State Psychiatric Institute
- Investigators
- Pablo Goldberg, M.D., Principal investigator, Columbia University/NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422290
- Sponsor's protocol ID
- #7023
- Status last verified
- Aug 2020
- First submitted
- 13 Apr 2015
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rauch SL, Wedig MM, Wright CI, Martis B, McMullin KG, Shin LM, Cannistraro PA, Wilhelm S. Functional magnetic resonance imaging study of regional brain activation during implicit sequence learning in obsessive-compulsive disorder. Biol Psychiatry. 2007 Feb 1;61(3):330-6. doi: 10.1016/j.biopsych.2005.12.012. Epub 2006 Feb 21.
PubMed 16497278Atmaca M, Yildirim H, Ozdemir H, Tezcan E, Poyraz AK. Volumetric MRI study of key brain regions implicated in obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):46-52. doi: 10.1016/j.pnpbp.2006.06.008. Epub 2006 Jul 20.
PubMed 16859819Graybiel AM, Rauch SL. Toward a neurobiology of obsessive-compulsive disorder. Neuron. 2000 Nov;28(2):343-7. doi: 10.1016/s0896-6273(00)00113-6. No abstract available.
PubMed 11144344Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.
PubMed 15841109Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1096-103. doi: 10.1097/00004583-200009000-00008.
PubMed 10986805Rodriguez CI, Bender J Jr, Marcus SM, Snape M, Rynn M, Simpson HB. Minocycline augmentation of pharmacotherapy in obsessive-compulsive disorder: an open-label trial. J Clin Psychiatry. 2010 Sep;71(9):1247-9. doi: 10.4088/JCP.09l05805blu.
PubMed 20923629Coric V, Milanovic S, Wasylink S, Patel P, Malison R, Krystal JH. Beneficial effects of the antiglutamatergic agent riluzole in a patient diagnosed with obsessive-compulsive disorder and major depressive disorder. Psychopharmacology (Berl). 2003 May;167(2):219-20. doi: 10.1007/s00213-003-1396-z. Epub 2003 Mar 26. No abstract available.
PubMed 12658528Stewart SE, Jenike EA, Hezel DM, Stack DE, Dodman NH, Shuster L, Jenike MA. A single-blinded case-control study of memantine in severe obsessive-compulsive disorder. J Clin Psychopharmacol. 2010 Feb;30(1):34-9. doi: 10.1097/JCP.0b013e3181c856de.
PubMed 20075645Hezel DM, Beattie K, Stewart SE. Memantine as an augmenting agent for severe pediatric OCD. Am J Psychiatry. 2009 Feb;166(2):237. doi: 10.1176/appi.ajp.2008.08091427. No abstract available.
PubMed 19188297Rynn M, Puliafico A, Heleniak C, Rikhi P, Ghalib K, Vidair H. Advances in pharmacotherapy for pediatric anxiety disorders. Depress Anxiety. 2011 Jan;28(1):76-87. doi: 10.1002/da.20769.
PubMed 21225851Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Oral ketamine premedication can prevent emergence agitation in children after desflurane anaesthesia. Paediatr Anaesth. 2004 Jun;14(6):477-82. doi: 10.1111/j.1460-9592.2004.01224.x.
PubMed 15153210Dahmani S, Michelet D, Abback PS, Wood C, Brasher C, Nivoche Y, Mantz J. Ketamine for perioperative pain management in children: a meta-analysis of published studies. Paediatr Anaesth. 2011 Jun;21(6):636-52. doi: 10.1111/j.1460-9592.2011.03566.x. Epub 2011 Mar 29.
PubMed 21447047Finkel JC, Pestieau SR, Quezado ZM. Ketamine as an adjuvant for treatment of cancer pain in children and adolescents. J Pain. 2007 Jun;8(6):515-21. doi: 10.1016/j.jpain.2007.02.429. Epub 2007 Apr 16.
PubMed 17434801Rodriguez CI, Kegeles LS, Levinson A, Feng T, Marcus SM, Vermes D, Flood P, Simpson HB. Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: proof-of-concept. Neuropsychopharmacology. 2013 Nov;38(12):2475-83. doi: 10.1038/npp.2013.150. Epub 2013 Jun 19.
PubMed 23783065Berman 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT02422290
- Acronym / sponsor ID
- #7023
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Ketamine, Glutamate, OCD treatment, OCD medication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Study start
- Mar 2015 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is proposed to determine the acceptability, feasibility and potential efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of the 14-day treatment phase, all participants will be offered three months of open treatment for OCD with medication and/or CBT.
Detailed description
See Brief Summary for description.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents and young adults with OCD | Experimental | Drug: KetamineAll participants will be receive the intravenous ketamine infusion. |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Participant must be 14-22 years of age at the time of consent (post-pubertal)
- Participant and a parent/guardian must be able to read and understand English
- Participant must be physically healthy and weigh at least 25kg. If female, must not be pregnant.
- Participant must fulfill DSM-V criteria for OCD, OCD being the principal disorder (i.e., currently the most severe and in need of treatment) and have had OCD for at least six months.
- Participant must score ≥ 16 on the Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS) prior to entering the study, report at least moderate severity of obsessions and/or compulsions..
Key exclusion criteria (16 listed)
- Family history of psychosis or substance abuse/dependence.
- History of violence
- Presence of psychotic symptoms or lifetime diagnosis of schizophrenia including any auditory or visual hallucinations or presence of delusional thinking, bipolar disorder, substance-induced psychotic disorder, psychosis due to general medical condition.
- Severely depressed patients with the Children's Depression Rating Scale (CDRS) ≥ 60 or judged clinically to be at risk of suicide.
- Current diagnosis of an eating disorder.
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: KetalarSingle infusion of IV Ketamine, 0.5mg/kg | Drug | Adolescents and young adults with OCD |
Primary outcome
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
The CY-BOCS is a semi-structured measure of OCD severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language. The CY-BOCS consists of 10 items which are summed up to derive the total CY-BOCS score. The total score ranges from 0-40 with higher scores indicating greater severity of OCD symptoms.
Clinical Global Impressions - Severity Scale (CGI-S)
Time frame: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
The CGI-S is a clinician rated 7-point rating scale for the severity of a participant's illness relative to the clinician's experience of working with this particular population. The score ranges from 1-7 with higher scores indicating greater illness severity.
2 secondary outcomes
OCD Visual Analogue Scale (OCD-VAS)
Time frame: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
Yale-Brown Obsessive Compulsive Challenge Scale (Y-BOCCS)
Time frame: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16497278Rauch SL, Wedig MM, Wright CI, Martis B, McMullin KG, Shin LM, Cannistraro PA, Wilhelm S. Functional magnetic resonance imaging study of regional brain activation during implicit sequence learning in obsessive-compulsive disorder. Biol Psychiatry. 2007 Feb 1;61(3):330-6. doi: 10.1016/j.biopsych.2005.12.012. Epub 2006 Feb 21.
- Background: PubMed 16859819Atmaca M, Yildirim H, Ozdemir H, Tezcan E, Poyraz AK. Volumetric MRI study of key brain regions implicated in obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):46-52. doi: 10.1016/j.pnpbp.2006.06.008. Epub 2006 Jul 20.
- Background: PubMed 11144344Graybiel AM, Rauch SL. Toward a neurobiology of obsessive-compulsive disorder. Neuron. 2000 Nov;28(2):343-7. doi: 10.1016/s0896-6273(00)00113-6. No abstract available.
- Background: PubMed 15841109Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.
- Background: PubMed 10986805Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1096-103. doi: 10.1097/00004583-200009000-00008.
- Background: PubMed 20923629Rodriguez CI, Bender J Jr, Marcus SM, Snape M, Rynn M, Simpson HB. Minocycline augmentation of pharmacotherapy in obsessive-compulsive disorder: an open-label trial. J Clin Psychiatry. 2010 Sep;71(9):1247-9. doi: 10.4088/JCP.09l05805blu.
- Background: PubMed 12658528Coric V, Milanovic S, Wasylink S, Patel P, Malison R, Krystal JH. Beneficial effects of the antiglutamatergic agent riluzole in a patient diagnosed with obsessive-compulsive disorder and major depressive disorder. Psychopharmacology (Berl). 2003 May;167(2):219-20. doi: 10.1007/s00213-003-1396-z. Epub 2003 Mar 26. No abstract available.
- Background: PubMed 20075645Stewart SE, Jenike EA, Hezel DM, Stack DE, Dodman NH, Shuster L, Jenike MA. A single-blinded case-control study of memantine in severe obsessive-compulsive disorder. J Clin Psychopharmacol. 2010 Feb;30(1):34-9. doi: 10.1097/JCP.0b013e3181c856de.
- Background: PubMed 19188297Hezel DM, Beattie K, Stewart SE. Memantine as an augmenting agent for severe pediatric OCD. Am J Psychiatry. 2009 Feb;166(2):237. doi: 10.1176/appi.ajp.2008.08091427. No abstract available.
- Background: PubMed 21225851Rynn M, Puliafico A, Heleniak C, Rikhi P, Ghalib K, Vidair H. Advances in pharmacotherapy for pediatric anxiety disorders. Depress Anxiety. 2011 Jan;28(1):76-87. doi: 10.1002/da.20769.
- Background: PubMed 15153210Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Oral ketamine premedication can prevent emergence agitation in children after desflurane anaesthesia. Paediatr Anaesth. 2004 Jun;14(6):477-82. doi: 10.1111/j.1460-9592.2004.01224.x.
- Background: PubMed 21447047Dahmani S, Michelet D, Abback PS, Wood C, Brasher C, Nivoche Y, Mantz J. Ketamine for perioperative pain management in children: a meta-analysis of published studies. Paediatr Anaesth. 2011 Jun;21(6):636-52. doi: 10.1111/j.1460-9592.2011.03566.x. Epub 2011 Mar 29.
- Individual participant dataSharing planned: No
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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.
Pablo Goldberg, M.D. principal investigator
Columbia University/NYSPI
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 Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute 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 16 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 17 Aug 2020. 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.
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?
Yes. Results are posted in the registry (first posted 17 Aug 2020). 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?
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (time frame: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported). 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 NCT02422290, which also lists 23 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 17 Aug 2020.