Rapid Antidepressant Effects of Ketamine in Major Depression
NCT ID: NCT00088699
Last Updated: 2018-10-12
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
67 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-07-26
Study Completion Date
2017-07-31
Brief Summary
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Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.
This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.
This study was designed to address the questions:
Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.
This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.
This study was designed to address the questions:
Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.
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Detailed Description
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This study will test whether a single dose of ketamine - a drug that blocks a brain receptor called NMDA - can cause a rapid (next day) antidepressant effect in patients with major depression. Several medications are effective for treating depression; however, they take weeks or months to achieve their full effects. A more rapidly acting antidepressant would have a significant impact on the treatment of depression. In a previous study, ketamine produced a rapid antidepressant effect within hours, but the effect lasted less than 1 week. Understanding how ketamine works may lead to a better understanding of the causes of depression and the design of a longer lasting rapidly acting antidepressant.
Patients between 18 and 65 years of age who are currently experiencing an episode of major depression of at least 4 weeks duration and have not responded to two treatment trials may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, and blood and urine tests.
Participants undergo the following tests and procedures:
Medication tapering: Patients who are taking medications for depression are tapered off the drugs over a 1- to 2-week period.
Ketamine/placebo trial: Patients are given a single dose of either ketamine or placebo (an inactive substance), administered intravenously (through a vein) over 40 minutes. After 7 days, patients are given another dose of study drug in crossover fashion; that is, those who previously took ketamine are switched to receive placebo, and those who took placebo are switched to ketamine. Oximetry (measurement of blood oxygen), pulse, and blood pressure are measured continuously for 1 hour before and 4 hours after each ketamine or placebo dose to monitor safety.
Interviews and rating scales: Patients complete a series of psychiatric rating scales to assess the effects of the study drug on mood and thinking. The rating scales are repeated up to 18 times during the study, with each time taking about 15 to 20 minutes.
Physical examination and laboratory tests: Patients have a physical examination, blood tests, weight measure, and electrocardiogram (ECG) at the beginning and end of the study. They will also have multi-modal MRI, MEG, polysomnography and serum marker studies.
The primary endpoint will be the change in clinical ratings of depression. Secondary endpoints will examine neurobiological correlates (i.e., multi-modal MRI, MEG, polysomnography and serum markers) of antidepressant response to ketamine (compared to placebo).
Patients between 18 and 65 years of age who are currently experiencing an episode of major depression of at least 4 weeks duration and have not responded to two treatment trials may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, and blood and urine tests.
Participants undergo the following tests and procedures:
Medication tapering: Patients who are taking medications for depression are tapered off the drugs over a 1- to 2-week period.
Ketamine/placebo trial: Patients are given a single dose of either ketamine or placebo (an inactive substance), administered intravenously (through a vein) over 40 minutes. After 7 days, patients are given another dose of study drug in crossover fashion; that is, those who previously took ketamine are switched to receive placebo, and those who took placebo are switched to ketamine. Oximetry (measurement of blood oxygen), pulse, and blood pressure are measured continuously for 1 hour before and 4 hours after each ketamine or placebo dose to monitor safety.
Interviews and rating scales: Patients complete a series of psychiatric rating scales to assess the effects of the study drug on mood and thinking. The rating scales are repeated up to 18 times during the study, with each time taking about 15 to 20 minutes.
Physical examination and laboratory tests: Patients have a physical examination, blood tests, weight measure, and electrocardiogram (ECG) at the beginning and end of the study. They will also have multi-modal MRI, MEG, polysomnography and serum marker studies.
The primary endpoint will be the change in clinical ratings of depression. Secondary endpoints will examine neurobiological correlates (i.e., multi-modal MRI, MEG, polysomnography and serum markers) of antidepressant response to ketamine (compared to placebo).
Conditions
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Depression
Mood Disorders
Major Depresssion
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Ketamine, Then Placebo
Ketamine and placebo infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg.
Group Type
EXPERIMENTAL
Ketamine
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Placebo, Then Ketamine
Placebo and Ketamine infusions were administered two weeks apart, with Ketamine's dose being 0.5 mg/kg
Group Type
EXPERIMENTAL
Ketamine
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Interventions
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Ketamine
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Male or female subjects, 18 to 65 years of age.
2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
3. Subjects must fulfill DSM-IV criteria for Major Depressive Disorder (MDD) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
4. Subjects must have an initial score of at least 20 on the MADRS at screen and at baseline of study phase I.
5. Subjects must have failed to respond in the past to an adequate dose and duration of at least one antidepressant (SSRI, bupropion, or venlafaxine) during a depressive episode
6. Current depressive episode of at least 4 weeks duration.
1. Age of onset less than 40 years of age.
2. Subjects with MDD must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).
3. A failed adequate trial of ECT would count as an adequate antidepressant trial.
4. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
1. Age 18-65 years.
2. Written informed consent completed.
2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
3. Subjects must fulfill DSM-IV criteria for Major Depressive Disorder (MDD) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
4. Subjects must have an initial score of at least 20 on the MADRS at screen and at baseline of study phase I.
5. Subjects must have failed to respond in the past to an adequate dose and duration of at least one antidepressant (SSRI, bupropion, or venlafaxine) during a depressive episode
6. Current depressive episode of at least 4 weeks duration.
1. Age of onset less than 40 years of age.
2. Subjects with MDD must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).
3. A failed adequate trial of ECT would count as an adequate antidepressant trial.
4. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
1. Age 18-65 years.
2. Written informed consent completed.
Exclusion Criteria
1. Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
3. Female subjects who are either pregnant or nursing.
4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
5. Subjects with uncorrected hypothyroidism or hyperthyroidism.
6. Subjects with one or more seizures without a clear and resolved etiology.
7. Treatment with a reversible MAOI within 4 weeks prior to study phase I.
8. Treatment with fluoxetine within 5 weeks prior to study phase I.
9. Treatment with any other concomitant medication not allowed (Appendix A for Substudy 2; Appendix G for Substudy 4) 14 days prior to study phase I.
10. No structured psychotherapy will be permitted during the study.
11. Current NIMH employee/staff or their immediate family member.
1\. Previous treatment with ketamine or hypersensitivity to amantadine.
1. Subjects who currently are using drugs (except for caffeine or nicotine), must not have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
2. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
3. Clinically significant abnormal laboratory tests.
4. For imaging procedures, Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
5. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of \>4.
1. Current or past Axis I diagnosis
2. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
3. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
4. Treatment with any of the exclusionary medications detailed in Appendix G 14 days prior to Phase 1 of the Substudy 4.
5. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
6. Presence of psychiatric disorders in first-degree relatives.
7. Female subjects who are either pregnant or nursing.
7.8.Current NIMH employee/staff or their immediate family member.
2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
3. Female subjects who are either pregnant or nursing.
4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
5. Subjects with uncorrected hypothyroidism or hyperthyroidism.
6. Subjects with one or more seizures without a clear and resolved etiology.
7. Treatment with a reversible MAOI within 4 weeks prior to study phase I.
8. Treatment with fluoxetine within 5 weeks prior to study phase I.
9. Treatment with any other concomitant medication not allowed (Appendix A for Substudy 2; Appendix G for Substudy 4) 14 days prior to study phase I.
10. No structured psychotherapy will be permitted during the study.
11. Current NIMH employee/staff or their immediate family member.
1\. Previous treatment with ketamine or hypersensitivity to amantadine.
1. Subjects who currently are using drugs (except for caffeine or nicotine), must not have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
2. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
3. Clinically significant abnormal laboratory tests.
4. For imaging procedures, Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
5. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of \>4.
1. Current or past Axis I diagnosis
2. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
3. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
4. Treatment with any of the exclusionary medications detailed in Appendix G 14 days prior to Phase 1 of the Substudy 4.
5. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
6. Presence of psychiatric disorders in first-degree relatives.
7. Female subjects who are either pregnant or nursing.
7.8.Current NIMH employee/staff or their immediate family member.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Carlos A Zarate, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Site Status
Countries
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United States
References
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Nugent AC, Ballard ED, Gould TD, Park LT, Moaddel R, Brutsche NE, Zarate CA Jr. Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects. Mol Psychiatry. 2019 Jul;24(7):1040-1052. doi: 10.1038/s41380-018-0028-2. Epub 2018 Feb 27.
Reference Type
RESULT
Evans JW, Lally N, An L, Li N, Nugent AC, Banerjee D, Snider SL, Shen J, Roiser JP, Zarate CA Jr. 7T 1H-MRS in major depressive disorder: a Ketamine Treatment Study. Neuropsychopharmacology. 2018 Aug;43(9):1908-1914. doi: 10.1038/s41386-018-0057-1. Epub 2018 Apr 5.
Reference Type
RESULT
Gilbert JR, Yarrington JS, Wills KE, Nugent AC, Zarate CA. Glutamatergic Signaling Drives Ketamine-Mediated Response in Depression: Evidence from Dynamic Causal Modeling. Int J Neuropsychopharmacol. 2018 Aug 1;21(8):740-747. doi: 10.1093/ijnp/pyy041.
Reference Type
RESULT
Evans JW, Szczepanik J, Brutsche N, Park LT, Nugent AC, Zarate CA Jr. Default Mode Connectivity in Major Depressive Disorder Measured Up to 10 Days After Ketamine Administration. Biol Psychiatry. 2018 Oct 15;84(8):582-590. doi: 10.1016/j.biopsych.2018.01.027. Epub 2018 Feb 15.
Reference Type
RESULT
Nugent AC, Zarate CA Jr. Using Neuroimaging to Decipher the Mechanism of Action of Ketamine: A Pathway to Novel Therapeutics? Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Oct;2(7):549-551. doi: 10.1016/j.bpsc.2017.08.006. Epub 2017 Oct 5. No abstract available.
Reference Type
RESULT
Kadriu B, Gold PW, Luckenbaugh DA, Lener MS, Ballard ED, Niciu MJ, Henter ID, Park LT, De Sousa RT, Yuan P, Machado-Vieira R, Zarate CA. Acute ketamine administration corrects abnormal inflammatory bone markers in major depressive disorder. Mol Psychiatry. 2018 Jul;23(7):1626-1631. doi: 10.1038/mp.2017.109. Epub 2017 May 30.
Reference Type
RESULT
Kheirkhah M, Hejazi NS, Nugent AC, Gilbert JR, Leistritz L, Walter M, Duncan WC Jr, Goldman D, Zarate CA Jr. Exploring the link between waking gamma and sleep delta power in healthy volunteers and individuals with treatment-resistant depression. J Affect Disord. 2025 Sep 15;385:119448. doi: 10.1016/j.jad.2025.119448. Epub 2025 May 19.
Reference Type
DERIVED
Kheirkhah M, Duncan WC Jr, Yuan Q, Wang PR, Jamalabadi H, Leistritz L, Walter M, Goldman D, Zarate CA Jr, Hejazi NS. REM density predicts rapid antidepressant response to ketamine in individuals with treatment-resistant depression. Neuropsychopharmacology. 2025 May;50(6):941-946. doi: 10.1038/s41386-025-02066-7. Epub 2025 Feb 15.
Reference Type
DERIVED
Ballard ED, Greenstein D, Reiss PT, Crainiceanu CM, Cui E, Duncan WC Jr, Hejazi NS, Zarate CA Jr. Functional changes in sleep-related arousal after ketamine administration in individuals with treatment-resistant depression. Transl Psychiatry. 2024 Jun 4;14(1):238. doi: 10.1038/s41398-024-02956-2.
Reference Type
DERIVED
Alexander L, Hawkins PCT, Evans JW, Mehta MA, Zarate CA Jr. Preliminary evidence that ketamine alters anterior cingulate resting-state functional connectivity in depressed individuals. Transl Psychiatry. 2023 Dec 1;13(1):371. doi: 10.1038/s41398-023-02674-1.
Reference Type
DERIVED
Punturieri C, Duncan WC Jr, Greenstein D, Shandler G, Zarate CA Jr, Evans JW. An exploration of actigraphy in the context of ketamine and treatment-resistant depression. Int J Methods Psychiatr Res. 2023 Sep 5;33(1):e1984. doi: 10.1002/mpr.1984. Online ahead of print.
Reference Type
DERIVED
Quintanilla B, Medeiros GC, Greenstein D, Yuan P, Johnston JN, Park LT, Goes FS, Gould TD, Zarate CA Jr. kappa-Opioid Receptor Plasma Levels Are Associated With Sex and Diagnosis of Major Depressive Disorder But Not Response to Ketamine. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):89-96. doi: 10.1097/JCP.0000000000001663.
Reference Type
DERIVED
Hejazi NS, Farmer CA, Oppenheimer M, Falodun TB, Park LT, Duncan WC Jr, Zarate CA Jr. The relationship between the HDRS insomnia items and polysomnographic (PSG) measures in individuals with treatment-resistant depression. J Psychiatr Res. 2022 Apr;148:27-33. doi: 10.1016/j.jpsychires.2022.01.022. Epub 2022 Jan 11.
Reference Type
DERIVED
Dean RL, Marquardt T, Hurducas C, Spyridi S, Barnes A, Smith R, Cowen PJ, McShane R, Hawton K, Malhi GS, Geddes J, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with bipolar disorder. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD011611. doi: 10.1002/14651858.CD011611.pub3.
Reference Type
DERIVED
Gilbert JR, Galiano CS, Nugent AC, Zarate CA. Ketamine and Attentional Bias Toward Emotional Faces: Dynamic Causal Modeling of Magnetoencephalographic Connectivity in Treatment-Resistant Depression. Front Psychiatry. 2021 Jun 18;12:673159. doi: 10.3389/fpsyt.2021.673159. eCollection 2021.
Reference Type
DERIVED
Acevedo-Diaz EE, Greenwald M, Cavanaugh GW, Greenstein DK, Kraus C, Kadriu B, Zarate CA Jr, Park LT. Reply to: "Letter to the Editor: Are ketamine-induced subjective bodily experiences associated with antidepressant effects? A sensation of floating and a sensation of Lightnessare not the same - A comment on Acevedo-Diaz et al." (Jpsychiatrres-D-21-00121). J Psychiatr Res. 2021 May;137:409-410. doi: 10.1016/j.jpsychires.2021.03.018. Epub 2021 Mar 16. No abstract available.
Reference Type
DERIVED
Lundin NB, Sepe-Forrest L, Gilbert JR, Carver FW, Furey ML, Zarate CA Jr, Nugent AC. Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder. J Affect Disord. 2021 Jan 15;279:239-249. doi: 10.1016/j.jad.2020.10.007. Epub 2020 Oct 7.
Reference Type
DERIVED
Mkrtchian A, Evans JW, Kraus C, Yuan P, Kadriu B, Nugent AC, Roiser JP, Zarate CA Jr. Ketamine modulates fronto-striatal circuitry in depressed and healthy individuals. Mol Psychiatry. 2021 Jul;26(7):3292-3301. doi: 10.1038/s41380-020-00878-1. Epub 2020 Sep 14.
Reference Type
DERIVED
Nugent AC, Ballard ED, Gilbert JR, Tewarie PK, Brookes MJ, Zarate CA Jr. Multilayer MEG functional connectivity as a potential marker for suicidal thoughts in major depressive disorder. Neuroimage Clin. 2020;28:102378. doi: 10.1016/j.nicl.2020.102378. Epub 2020 Aug 8.
Reference Type
DERIVED
Kraus C, Mkrtchian A, Kadriu B, Nugent AC, Zarate CA Jr, Evans JW. Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment. Neuropsychopharmacology. 2020 May;45(6):982-989. doi: 10.1038/s41386-020-0624-0. Epub 2020 Jan 29.
Reference Type
DERIVED
Gilbert JR, Ballard ED, Galiano CS, Nugent AC, Zarate CA Jr. Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):354-363. doi: 10.1016/j.bpsc.2019.11.011. Epub 2019 Dec 3.
Reference Type
DERIVED
Acevedo-Diaz EE, Cavanaugh GW, Greenstein D, Kraus C, Kadriu B, Zarate CA, Park LT. Comprehensive assessment of side effects associated with a single dose of ketamine in treatment-resistant depression. J Affect Disord. 2020 Feb 15;263:568-575. doi: 10.1016/j.jad.2019.11.028. Epub 2019 Nov 10.
Reference Type
DERIVED
Kadriu B, Farmer CA, Yuan P, Park LT, Deng ZD, Moaddel R, Henter ID, Shovestul B, Ballard ED, Kraus C, Gold PW, Machado-Vieira R, Zarate CA Jr. The kynurenine pathway and bipolar disorder: intersection of the monoaminergic and glutamatergic systems and immune response. Mol Psychiatry. 2021 Aug;26(8):4085-4095. doi: 10.1038/s41380-019-0589-8. Epub 2019 Nov 15.
Reference Type
DERIVED
Reed JL, Nugent AC, Furey ML, Szczepanik JE, Evans JW, Zarate CA Jr. Effects of Ketamine on Brain Activity During Emotional Processing: Differential Findings in Depressed Versus Healthy Control Participants. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Jul;4(7):610-618. doi: 10.1016/j.bpsc.2019.01.005. Epub 2019 Jan 25.
Reference Type
DERIVED
Ballard ED, Reed JL, Szczepanik J, Evans JW, Yarrington JS, Dickstein DP, Nock MK, Nugent AC, Zarate CA Jr. Functional Imaging of the Implicit Association of the Self With Life and Death. Suicide Life Threat Behav. 2019 Dec;49(6):1600-1608. doi: 10.1111/sltb.12543. Epub 2019 Feb 13.
Reference Type
DERIVED
Nugent AC, Wills KE, Gilbert JR, Zarate CA Jr. Synaptic potentiation and rapid antidepressant response to ketamine in treatment-resistant major depression: A replication study. Psychiatry Res Neuroimaging. 2019 Jan 30;283:64-66. doi: 10.1016/j.pscychresns.2018.09.001. Epub 2018 Sep 12.
Reference Type
DERIVED
Ballard ED, Yarrington JS, Farmer CA, Richards E, Machado-Vieira R, Kadriu B, Niciu MJ, Yuan P, Park L, Zarate CA Jr. Characterizing the course of suicidal ideation response to ketamine. J Affect Disord. 2018 Dec 1;241:86-93. doi: 10.1016/j.jad.2018.07.077. Epub 2018 Jul 30.
Reference Type
DERIVED
Reed JL, Nugent AC, Furey ML, Szczepanik JE, Evans JW, Zarate CA Jr. Ketamine normalizes brain activity during emotionally valenced attentional processing in depression. Neuroimage Clin. 2018 Jul 5;20:92-101. doi: 10.1016/j.nicl.2018.07.006. eCollection 2018.
Reference Type
DERIVED
Ballard ED, Yarrington JS, Farmer CA, Lener MS, Kadriu B, Lally N, Williams D, Machado-Vieira R, Niciu MJ, Park L, Zarate CA Jr. Parsing the heterogeneity of depression: An exploratory factor analysis across commonly used depression rating scales. J Affect Disord. 2018 Apr 15;231:51-57. doi: 10.1016/j.jad.2018.01.027. Epub 2018 Feb 5.
Reference Type
DERIVED
Duncan WC Jr, Slonena E, Hejazi NS, Brutsche N, Yu KC, Park L, Ballard ED, Zarate CA Jr. Motor-Activity Markers of Circadian Timekeeping Are Related to Ketamine's Rapid Antidepressant Properties. Biol Psychiatry. 2017 Sep 1;82(5):361-369. doi: 10.1016/j.biopsych.2017.03.011. Epub 2017 Mar 28.
Reference Type
DERIVED
Vande Voort JL, Ballard ED, Luckenbaugh DA, Bernert RA, Richards EM, Niciu MJ, Park LT, Machado-Vieira R, Duncan WC Jr, Zarate CA Jr. Antisuicidal Response Following Ketamine Infusion Is Associated With Decreased Nighttime Wakefulness in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2017 Sep/Oct;78(8):1068-1074. doi: 10.4088/JCP.15m10440.
Reference Type
DERIVED
Lepow L, Luckenbaugh DA, Park L, Henter ID, Zarate CA Jr. Case series: Antidepressant effects of low-affinity and low-trapping NMDA receptor antagonists did not predict response to ketamine in seven subjects. J Psychiatr Res. 2017 Mar;86:55-57. doi: 10.1016/j.jpsychires.2016.10.023. Epub 2016 Nov 22. No abstract available.
Reference Type
DERIVED
Pennybaker SJ, Niciu MJ, Luckenbaugh DA, Zarate CA. Symptomatology and predictors of antidepressant efficacy in extended responders to a single ketamine infusion. J Affect Disord. 2017 Jan 15;208:560-566. doi: 10.1016/j.jad.2016.10.026. Epub 2016 Oct 26.
Reference Type
DERIVED
Bernert RA, Luckenbaugh DA, Duncan WC, Iwata NG, Ballard ED, Zarate CA. Sleep architecture parameters as a putative biomarker of suicidal ideation in treatment-resistant depression. J Affect Disord. 2017 Jan 15;208:309-315. doi: 10.1016/j.jad.2016.08.050. Epub 2016 Oct 14.
Reference Type
DERIVED
Park M, Newman LE, Gold PW, Luckenbaugh DA, Yuan P, Machado-Vieira R, Zarate CA Jr. Change in cytokine levels is not associated with rapid antidepressant response to ketamine in treatment-resistant depression. J Psychiatr Res. 2017 Jan;84:113-118. doi: 10.1016/j.jpsychires.2016.09.025. Epub 2016 Sep 30.
Reference Type
DERIVED
Berg HE, Ballard ED, Luckenbaugh DA, Nugent AC, Ionescu DF, Zarate CA Jr. Recognition of emotional facial expressions in anxious and nonanxious depression. Compr Psychiatry. 2016 Oct;70:1-8. doi: 10.1016/j.comppsych.2016.06.007. Epub 2016 Jun 14.
Reference Type
DERIVED
Ballard ED, Vande Voort JL, Luckenbaugh DA, Machado-Vieira R, Tohen M, Zarate CA. Acute risk factors for suicide attempts and death: prospective findings from the STEP-BD study. Bipolar Disord. 2016 Jun;18(4):363-72. doi: 10.1111/bdi.12397. Epub 2016 May 27.
Reference Type
DERIVED
Ballard ED, Luckenbaugh DA, Richards EM, Walls TL, Brutsche NE, Ameli R, Niciu MJ, Vande Voort JL, Zarate CA Jr. Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant. J Psychiatr Res. 2015 Sep;68:68-73. doi: 10.1016/j.jpsychires.2015.06.003. Epub 2015 Jun 16.
Reference Type
DERIVED
Luckenbaugh DA, Ameli R, Brutsche NE, Zarate CA Jr. Rating depression over brief time intervals with the Hamilton Depression Rating Scale: standard vs. abbreviated scales. J Psychiatr Res. 2015 Feb;61:40-5. doi: 10.1016/j.jpsychires.2014.12.015. Epub 2014 Dec 27.
Reference Type
DERIVED
Ortiz R, Niciu MJ, Lukkahati N, Saligan LN, Nugent AC, Luckenbaugh DA, Machado-Vieira R, Zarate CA Jr. Shank3 as a potential biomarker of antidepressant response to ketamine and its neural correlates in bipolar depression. J Affect Disord. 2015 Feb 1;172:307-11. doi: 10.1016/j.jad.2014.09.015. Epub 2014 Oct 16.
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Ionescu DF, Luckenbaugh DA, Niciu MJ, Richards EM, Zarate CA Jr. A single infusion of ketamine improves depression scores in patients with anxious bipolar depression. Bipolar Disord. 2015 Jun;17(4):438-43. doi: 10.1111/bdi.12277. Epub 2014 Nov 14.
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Ionescu DF, Luckenbaugh DA, Niciu MJ, Richards EM, Slonena EE, Vande Voort JL, Brutsche NE, Zarate CA Jr. Effect of baseline anxious depression on initial and sustained antidepressant response to ketamine. J Clin Psychiatry. 2014 Sep;75(9):e932-8. doi: 10.4088/JCP.14m09049.
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Ballard ED, Ionescu DF, Vande Voort JL, Niciu MJ, Richards EM, Luckenbaugh DA, Brutsche NE, Ameli R, Furey ML, Zarate CA Jr. Improvement in suicidal ideation after ketamine infusion: relationship to reductions in depression and anxiety. J Psychiatr Res. 2014 Nov;58:161-6. doi: 10.1016/j.jpsychires.2014.07.027. Epub 2014 Aug 12.
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Cornwell BR, Salvadore G, Furey M, Marquardt CA, Brutsche NE, Grillon C, Zarate CA Jr. Synaptic potentiation is critical for rapid antidepressant response to ketamine in treatment-resistant major depression. Biol Psychiatry. 2012 Oct 1;72(7):555-61. doi: 10.1016/j.biopsych.2012.03.029. Epub 2012 Apr 21.
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Zarate CA Jr, Brutsche NE, Ibrahim L, Franco-Chaves J, Diazgranados N, Cravchik A, Selter J, Marquardt CA, Liberty V, Luckenbaugh DA. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry. 2012 Jun 1;71(11):939-46. doi: 10.1016/j.biopsych.2011.12.010. Epub 2012 Jan 31.
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Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.
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DiazGranados N, Ibrahim LA, Brutsche NE, Ameli R, Henter ID, Luckenbaugh DA, Machado-Vieira R, Zarate CA Jr. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J Clin Psychiatry. 2010 Dec;71(12):1605-11. doi: 10.4088/JCP.09m05327blu. Epub 2010 Jul 13.
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Machado-Vieira R, Yuan P, Brutsche N, DiazGranados N, Luckenbaugh D, Manji HK, Zarate CA Jr. Brain-derived neurotrophic factor and initial antidepressant response to an N-methyl-D-aspartate antagonist. J Clin Psychiatry. 2009 Dec;70(12):1662-6. doi: 10.4088/JCP.08m04659. Epub 2009 Sep 8.
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Phelps LE, Brutsche N, Moral JR, Luckenbaugh DA, Manji HK, Zarate CA Jr. Family history of alcohol dependence and initial antidepressant response to an N-methyl-D-aspartate antagonist. Biol Psychiatry. 2009 Jan 15;65(2):181-4. doi: 10.1016/j.biopsych.2008.09.029. Epub 2008 Nov 8.
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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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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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04-M-0222
Identifier Type: -
Identifier Source: secondary_id
040222
Identifier Type: -
Identifier Source: org_study_id
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