Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-04-30
Study Completion Date
2015-06-05
Brief Summary
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Treatment resistant depression (TRD) is a major public health problem. Current therapeutic options for this patient population remain limited. With all available treatments, only a sub-set of those patients who achieve an antidepressant response are likely to achieve treatment-induced remission. The need for antidepressant medication that can provide both rapid and long lasting relief of TRD symptoms is widely recognized. There is new evidence that drugs that block NMDA glutamate receptors (NMDA antagonists) are promising candidates for meeting this need. Existing studies in TRD have used only a low-dose, brief infusion of ketamine that would not be expected to re-sensitize the NMDA receptor; in agreement with this theory, these prior studies have found only temporary improvements of depression. Our key hypothesis is that a higher-dose, longer-term ketamine infusion, such as that used in chronic pain studies, would provide a more robust and lasting improvement from depression.
Accordingly, we will test whether a 100-hour ketamine infusion would be more effective than the standard 40-minute ketamine infusion currently used in other TRD studies. We will randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).
Accordingly, we will test whether a 100-hour ketamine infusion would be more effective than the standard 40-minute ketamine infusion currently used in other TRD studies. We will randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).
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Detailed Description
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This experiment is a pilot study involving up to 20 healthy males or females between the ages of 18-65 to test whether a 100-hour ketamine infusion plus clonidine would be more effective, with longer lasting results, then the standard 40-minute ketamine infusion (plus clonidine). Each of the 2 arms, will be evaluated using a between subject, double-blind, randomized design.
1. a. Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
2. a. Controlled 40-minute IV ketamine infusion b. clonidine safener PO prior to infusion c. up to 100-hour(+/-)IV placebo (saline) infusion
3. a. Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
4. a.Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
In both conditions, participants will be admitted to the Washington University School of Medicine Clinical Research Unit at Barnes-Jewish Hospital for approximately 108-hours (Monday morning-Friday evening). Pulse, blood pressure, pulse-oximetry, and an electrocardiogram strip will be routinely monitored. Serial labs and clinical/safety ratings will be done pre-, during, and post-infusion, with the last assessments being used to assure that subjects have returned to their "baseline" prior to discharge from the research unit. Participants will continue to see their primary psychiatrist throughout the study.
1. a. Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
2. a. Controlled 40-minute IV ketamine infusion b. clonidine safener PO prior to infusion c. up to 100-hour(+/-)IV placebo (saline) infusion
3. a. Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
4. a.Controlled up to 100-hour IV ketamine infusion b. clonidine safener PO prior to infusion
In both conditions, participants will be admitted to the Washington University School of Medicine Clinical Research Unit at Barnes-Jewish Hospital for approximately 108-hours (Monday morning-Friday evening). Pulse, blood pressure, pulse-oximetry, and an electrocardiogram strip will be routinely monitored. Serial labs and clinical/safety ratings will be done pre-, during, and post-infusion, with the last assessments being used to assure that subjects have returned to their "baseline" prior to discharge from the research unit. Participants will continue to see their primary psychiatrist throughout the study.
Conditions
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Depressive Disorder, Treatment-Resistant
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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ketamine 100-hour infusion
100-hour infusion of ketamine plus a safener (clonidine)
Group Type
EXPERIMENTAL
Ketamine
Intervention Type
DRUG
Controlled IV ketamine infusion (0.00225mg/kg-min. \[18% (0.0125 mg/kg-min.).
Clonidine
Intervention Type
DRUG
Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.
ketamine 40-minute infusion
40-minute ketamine infusion following a 100-hours +/- placebo (saline) infusion. Participants will also receive a safener (clonidine)
Group Type
ACTIVE_COMPARATOR
Ketamine
Intervention Type
DRUG
Controlled IV ketamine infusion (0.00225mg/kg-min. \[18% (0.0125 mg/kg-min.).
Clonidine
Intervention Type
DRUG
Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.
placebo
Intervention Type
DRUG
IV saline (i.e. placebo ketamine)
Interventions
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Ketamine
Controlled IV ketamine infusion (0.00225mg/kg-min. \[18% (0.0125 mg/kg-min.).
Intervention Type
DRUG
Clonidine
Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.
Intervention Type
DRUG
placebo
IV saline (i.e. placebo ketamine)
Intervention Type
DRUG
Other Intervention Names
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Ketalar
Ketalin
Ketalor
Catapares
saline
Eligibility Criteria
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Inclusion Criteria
1. males and females aged 18-65 years;
2. Diagnostic and Statistical Manual (DSM) IV diagnosis of Major Depressive Disorder, recurrent, severe;
3. depression must be considered treatment refractory as defined by Montgomery Asberg Depression Rating Scale (MADRS) score of 22 or above which is consistent with other studies;
4. on a stable dose of permitted antidepressant medication or no medication pre-infusion;
5. not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per PI's judgment;
6. no history of significant clinical or intolerable side effects or complications from clonidine;
7. if a female of child-bearing potential: not pregnant or breast feeding and agrees to use birth control during the time of pre-dosing and infusions; and
8. able to give informed consent.
2. Diagnostic and Statistical Manual (DSM) IV diagnosis of Major Depressive Disorder, recurrent, severe;
3. depression must be considered treatment refractory as defined by Montgomery Asberg Depression Rating Scale (MADRS) score of 22 or above which is consistent with other studies;
4. on a stable dose of permitted antidepressant medication or no medication pre-infusion;
5. not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per PI's judgment;
6. no history of significant clinical or intolerable side effects or complications from clonidine;
7. if a female of child-bearing potential: not pregnant or breast feeding and agrees to use birth control during the time of pre-dosing and infusions; and
8. able to give informed consent.
Exclusion Criteria
1. confirmed bipolar disorder, schizophrenia, or schizoaffective disorder;
2. current or recent substance abuse/dependence (or any lifetime recreational ketamine or PCP use);
3. any severe Axis II personality disorder or schizophrenia spectrum disorder that, in the PI's judgment, could confound diagnosis or adherence to treatment;
4. the presence of any abnormal laboratory findings or serious medical disorder or condition that may, in the judgment of the PI, confound the assessment of relevant biologic measures or diagnoses including: clinically significant organ system dysfunction; significant and uncontrolled endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease; coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the SA or AV node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); after evaluation, anyone determined to have a potentially compromised airway that could be difficult to intubate; fever; BMI less than 14.5; or any medical condition known to interfere with cognitive performance; medication-related exclusions include memantine, or any medication that could be considered contraindicated ketamine;
5. current treatment with any medication contraindicated with ketamine or clonidine;
6. lifetime illegal use of PCP or ketamine; no clinical use of ketamine for past 3 months
7. meets DSM-IV criteria for Mental Retardation;
8. currently hospitalized;
9. acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any prior serious attempts (e.g., those requiring hospitalization) at the PI's discretion;
10. is pregnant or breast-feeding; unwilling to use birth control if female of child bearing potential
11. unable to provide informed consent.
2. current or recent substance abuse/dependence (or any lifetime recreational ketamine or PCP use);
3. any severe Axis II personality disorder or schizophrenia spectrum disorder that, in the PI's judgment, could confound diagnosis or adherence to treatment;
4. the presence of any abnormal laboratory findings or serious medical disorder or condition that may, in the judgment of the PI, confound the assessment of relevant biologic measures or diagnoses including: clinically significant organ system dysfunction; significant and uncontrolled endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease; coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the SA or AV node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); after evaluation, anyone determined to have a potentially compromised airway that could be difficult to intubate; fever; BMI less than 14.5; or any medical condition known to interfere with cognitive performance; medication-related exclusions include memantine, or any medication that could be considered contraindicated ketamine;
5. current treatment with any medication contraindicated with ketamine or clonidine;
6. lifetime illegal use of PCP or ketamine; no clinical use of ketamine for past 3 months
7. meets DSM-IV criteria for Mental Retardation;
8. currently hospitalized;
9. acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any prior serious attempts (e.g., those requiring hospitalization) at the PI's discretion;
10. is pregnant or breast-feeding; unwilling to use birth control if female of child bearing potential
11. unable to provide informed consent.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Florida Atlantic University
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Eric Lenze, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
John W Newcomer, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Nuri B Farber, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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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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Siegel JS, Palanca BJA, Ances BM, Kharasch ED, Schweiger JA, Yingling MD, Snyder AZ, Nicol GE, Lenze EJ, Farber NB. Prolonged ketamine infusion modulates limbic connectivity and induces sustained remission of treatment-resistant depression. Psychopharmacology (Berl). 2021 Apr;238(4):1157-1169. doi: 10.1007/s00213-021-05762-6. Epub 2021 Jan 22.
Reference Type
DERIVED
Lenze EJ, Farber NB, Kharasch E, Schweiger J, Yingling M, Olney J, Newcomer JW. Ninety-six hour ketamine infusion with co-administered clonidine for treatment-resistant depression: A pilot randomised controlled trial. World J Biol Psychiatry. 2016 Apr;17(3):230-8. doi: 10.3109/15622975.2016.1142607. Epub 2016 Feb 26.
Reference Type
DERIVED
Other Identifiers
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201202157
Identifier Type: -
Identifier Source: org_study_id
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PHASE4
Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone
NCT02900092
COMPLETED
NA
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
NCT00149825
COMPLETED
PHASE2
Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
NCT00018902
COMPLETED
PHASE2/PHASE3
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
NCT00232167
TERMINATED
PHASE3
Riluzole to Treat Major Depression
NCT00026052
COMPLETED
PHASE2
Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Sleep Deprivation
NCT05893173
COMPLETED
Combination Treatment Study for Memory Impairment and Depression
NCT01658228
COMPLETED
PHASE4
Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent
NCT04171193
UNKNOWN
PHASE2
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
NCT00419003
COMPLETED
PHASE4
The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression
NCT00125957
COMPLETED
PHASE3
Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
NCT00928980
COMPLETED
NA
Treatment of Post-Traumatic Brain Injury (TBI) Depression
NCT00233103
COMPLETED
PHASE2
D-cycloserine for Major Depressive Disorder
NCT00408031
COMPLETED
PHASE2
A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation
NCT00794040
COMPLETED
PHASE2
Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
NCT03435744
COMPLETED
PHASE3
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
NCT00581009
COMPLETED
PHASE1/PHASE2
Fluoxetine vs. Brief Psychotherapy for Major Depression
NCT00714779
COMPLETED
NA