Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
NCT ID: NCT02422290
Last Updated: 2020-08-17
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
5 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-03-31
Study Completion Date
2020-07-31
Brief Summary
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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.
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Detailed Description
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See Brief Summary for description.
Conditions
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Obsessive-Compulsive Disorder
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Adolescents and young adults with OCD
All participants will be receive the intravenous ketamine infusion.
Group Type
EXPERIMENTAL
Ketamine
Intervention Type
DRUG
Single infusion of IV Ketamine, 0.5mg/kg
Interventions
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Ketamine
Single infusion of IV Ketamine, 0.5mg/kg
Intervention Type
DRUG
Other Intervention Names
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Ketalar
Eligibility Criteria
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Inclusion Criteria
1. Participant must be 14-22 years of age at the time of consent (post-pubertal)
2. Participant and a parent/guardian must be able to read and understand English
3. Participant must be physically healthy and weigh at least 25kg. If female, must not be pregnant.
4. 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.
5. 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..
6. 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.
* 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.
7. 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.
8. 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.
2. Participant and a parent/guardian must be able to read and understand English
3. Participant must be physically healthy and weigh at least 25kg. If female, must not be pregnant.
4. 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.
5. 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..
6. 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.
* 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.
7. 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.
8. 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.
Exclusion Criteria
1. Family history of psychosis or substance abuse/dependence.
2. History of violence
3. 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.
4. Severely depressed patients with the Children's Depression Rating Scale (CDRS) ≥ 60 or judged clinically to be at risk of suicide.
5. Current diagnosis of an eating disorder.
6. Current or past history of PTSD or significant trauma.
7. Current or past diagnosis of substance abuse/dependence.
8. 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.
9. 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.
10. Documented history of hypersensitivity or intolerance to ketamine.
11. 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.
12. 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.
13. 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.
14. Positive urine screen for illicit drugs
15. Inability of participant or parent/guardian to read or understand English.
16. Documented history of adverse reaction to anesthesia.
2. History of violence
3. 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.
4. Severely depressed patients with the Children's Depression Rating Scale (CDRS) ≥ 60 or judged clinically to be at risk of suicide.
5. Current diagnosis of an eating disorder.
6. Current or past history of PTSD or significant trauma.
7. Current or past diagnosis of substance abuse/dependence.
8. 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.
9. 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.
10. Documented history of hypersensitivity or intolerance to ketamine.
11. 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.
12. 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.
13. 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.
14. Positive urine screen for illicit drugs
15. Inability of participant or parent/guardian to read or understand English.
16. Documented history of adverse reaction to anesthesia.
Minimum Eligible Age
14 Years
Maximum Eligible Age
22 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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New York Presbyterian Hospital
OTHER
Sponsor Role
collaborator
New York State Psychiatric Institute
OTHER
Sponsor Role
lead
Responsible Party
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Pablo H. Goldberg
Clinical Psychiatrist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Pablo Goldberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University/NYSPI
Locations
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New York State Psychiatric Institute/Columbia University
New York, New York, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
Atmaca 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.
Reference Type
BACKGROUND
Graybiel 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.
Reference Type
BACKGROUND
Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40. doi: 10.1038/sj.npp.1300733.
Reference Type
BACKGROUND
Rosenberg 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.
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BACKGROUND
Rodriguez 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.
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BACKGROUND
Coric 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.
Reference Type
BACKGROUND
Stewart 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.
Reference Type
BACKGROUND
Hezel 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.
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BACKGROUND
Rynn 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.
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BACKGROUND
Kararmaz 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.
Reference Type
BACKGROUND
Dahmani 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.
Reference Type
BACKGROUND
Finkel 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.
Reference Type
BACKGROUND
Rodriguez 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
Marcus RJ, Victoria BA, Rushman SC, Thompson JP. Comparison of ketamine and morphine for analgesia after tonsillectomy in children. Br J Anaesth. 2000 Jun;84(6):739-42. doi: 10.1093/oxfordjournals.bja.a013585.
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BACKGROUND
Aspinall RL, Mayor A. A prospective randomized controlled study of the efficacy of ketamine for postoperative pain relief in children after adenotonsillectomy. Paediatr Anaesth. 2001 May;11(3):333-6. doi: 10.1046/j.1460-9592.2001.00676.x.
Reference Type
BACKGROUND
Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969.
Reference Type
BACKGROUND
Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.
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BACKGROUND
Correll CU. Assessing and maximizing the safety and tolerability of antipsychotics used in the treatment of children and adolescents. J Clin Psychiatry. 2008;69 Suppl 4:26-36.
Reference Type
BACKGROUND
Papolos DF, Teicher MH, Faedda GL, Murphy P, Mattis S. Clinical experience using intranasal ketamine in the treatment of pediatric bipolar disorder/fear of harm phenotype. J Affect Disord. 2013 May;147(1-3):431-6. doi: 10.1016/j.jad.2012.08.040. Epub 2012 Nov 30.
Reference Type
BACKGROUND
Ishimuro HS, Yanes-Lukin PK, Goldberg PH, Simpson HB, Rynn MA. Ketamine Treatment for Pediatric Refractory Obsessive: Five Open Label Cases. J Child Adolesc Psychopharmacol. 2025 Apr;35(3):167-170. doi: 10.1089/cap.2024.0127. Epub 2025 Feb 3.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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#7023
Identifier Type: -
Identifier Source: org_study_id
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