RishiKakarMD

Psychiatry • Miami Lakes, FL

Neuropsychiatry, Psychopharmacology, Psychosomatic Medicine, Integrative Psychiatry

Chief Scientific Officer/Medical Director

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Office
14211 Commerce Way
Miami Lakes, FL 33016
Phone+1 888-852-6672

Fax+1 305-891-4228
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Summary

I am board certified psychiatrist with additional training from National Institute of Mental Health. I am currently a Medical Director for a large research institute a and primary investigator for numerous phase I- IV clinical trials. I am actively conducting studies in depression,anxiety, bipolar, schizophrenia, pain, dementia and
substance use. I also have a clinical practice where I see adults and adolescents with various psychiatric disorders. I am especially interested in integrating mind body approaches, nutritional methods, ortho molecular techniques along with traditional pharmacological regimen to treat my patients.

Education & Training

Clinical Center at the National Institutes of HealthFellowship, Psychosomatic Medicine, 2010 - 2011
MedStar Health/Georgetown University HospitalResidency, Psychiatry, 2008 - 2010
Sidney Kimmel Medical College at Thomas Jefferson University/TJUHResidency, Neurology, 2007 - 2007
Saint Peter's University Hospital/Rutgers Robert Wood Johnson Medical SchoolInternship, Internal Medicine, 2006 - 2007
Albany Medical CollegeClass of 2006

Certifications & Licensure

CA State Medical License 2017 - Present
FL State Medical License 2011 - 2025
MD State Medical License 2010 - 2012
DC State Medical License 2008 - 2010
PA State Medical License 2007 - 2008
American Board of Psychiatry and Neurology Psychiatry

Awards, Honors, & Recognition

FL Top Doctor Award 2018
Elected member Alpha Omega Alpha, 2006

Clinical Trials

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia Start of enrollment: 2008 Sep 01
Completed
Phase 3
Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD) Start of enrollment: 2012 Nov 01
Completed
Phase 2
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD) Start of enrollment: 2013 Oct 01
Completed
Phase 2
A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia Start of enrollment: 2014 Mar 26
Completed
Phase 2
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients Start of enrollment: 2014 Apr 01
Completed
Phase 3
Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia Start of enrollment: 2014 Jun 01
Completed
Phase 3
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine Start of enrollment: 2015 Jan 28
Completed
Phase 3
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) Start of enrollment: 2015 Sep 01
Completed
Not Applicable
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder Start of enrollment: 2015 Jul 27
Completed
Phase 3
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) Start of enrollment: 2016 Feb 16
Completed
Phase 3
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence Start of enrollment: 2015 Dec 01
Completed
Phase 3
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant Start of enrollment: 2015 Oct 01
Completed
Phase 2
Clinical Study Evaluating Effects of Pharmacogenetic-guided vs Standard-of-Care Treatment on Depression and/or Anxiety Start of enrollment: 2016 May 01
Completed
Not Applicable
Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD Start of enrollment: 2018 May 11
Completed
Phase 2
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder Start of enrollment: 2017 Jun 12
Completed
Phase 2
Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD) Start of enrollment: 2017 Dec 04
Completed
Not Applicable
KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD Start of enrollment: 2018 Mar 13
Completed
Phase 3
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder Start of enrollment: 2018 Jul 13
Completed
Phase 3
A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder Start of enrollment: 2019 Jan 16
Completed
Phase 3
A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder Start of enrollment: 2019 Feb 14
Completed
Phase 3
Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression Start of enrollment: 2018 Jun 06
Completed
Phase 1
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. Start of enrollment: 2019 Nov 15
Completed
Phase 3
Single Ascending Dose Study of ALA-1000 Start of enrollment: 2019 Sep 16
Completed
Phase 1
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Start of enrollment: 2023 Feb 14
Recruiting
Phase 3
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Start of enrollment: 2021 Sep 08
Completed
Phase 1
ANC-501 in the Treatment of Adults With Major Depressive Disorder Start of enrollment: 2022 Sep 19
Active, not recruiting
Phase 2
The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes Start of enrollment: 2021 Mar 23
Recruiting
Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) Start of enrollment: 2022 May 06
Active, not recruiting
Phase 2
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Publications & Presentations

PubMed

1 citations
Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, p...
Kaul, I., Sawchak, S., Zhu, H., Miller, A., Paul, S., Brannan, S., Correll, C., Kakar, R., Breier, A.> ;Lancet. 2024 Jan 13
7 citations
Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial.
Leslie Citrome, Sheldon H Preskorn, John Lauriello, John H Krystal, Rishi Kakar, Jeffrey Finman, Michael De Vivo, Frank D Yocca, Robert Risinger, Lavanya Rajachandran> ;The Journal of Clinical Psychiatry. 2022 Oct 3
2 citations
Sublingual Dexmedetomidine vs Placebo and Acute Agitation Associated With Bipolar Disorder-Reply.
Sheldon H Preskorn, Robert Risinger, Rishi Kakar> ;JAMA. 2022 Jul 12
36 citations
Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder: A Randomized Clinical Trial.
Sheldon H Preskorn, Scott Zeller, Leslie Citrome, Jeffrey Finman, Joseph F Goldberg, Maurizio Fava, Rishi Kakar, Michael De Vivo, Frank D Yocca, Robert Risinger> ;JAMA. 2022 Feb 22
3 citations
Clinical and genetic analysis of CMT1B in a Nigerian family.
R. Kakar, W. Ma, A. Dutra, W.K. Seltzer, R.P. Grewal> ;Muscle & Nerve. 2003 May 1
146 citations
Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Barbara R. Haight, Susan M Learned, Céline M. Laffont, Paul J. Fudala, Y Zhao, Amanda S. Garofalo, Mark K. Greenwald, Vijay R Nadipelli, Walter Ling, Christian Heidbre...> ;Lancet. 2019 Feb 23
12 citations
Herpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study.
Alan Breier, Robert W. Buchanan, Deepak Cyril D'Souza, Keith H. Nuechterlein, Stephen R. Marder, Walter Dunn, Sheldon H. Preskorn, Matthew Macaluso, Brent E. Wurfel, G...> ;Schizophrenia Research. 2019 Apr 1
A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies.
Post A, Smart TS, Krikke-Workel J, Dawson GR, Harmer CJ, Browning M, Jackson K, Kakar R, Mohs R, Statnick M, Wafford K, McCarthy A, Barth V, Witkin JM> ;Neuropsychopharmacology. 2016-09-01
Erratum: A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies.
Anke Post, Trevor S Smart, Judith Krikke-Workel, Gerard R Dawson, Catherine J Harmer, Michael Browning, Kimberley Jackson, Rishi Kakar, Richard Mohs, Michael Statnick,...> ;Neuropsychopharmacology. 2016 Sep 1
Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial.
Rosenthal RN, Lofwall MR, Kim S, Chen M, Beebe KL, Vocci FJ> ;JAMA. 2016 Jul 19
15 citations
A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies.
Anke Post, Trevor S Smart, Judith Krikke-Workel, Gerard R Dawson, Catherine J Harmer, Michael Browning, Kimberley Jackson, Rishi Kakar, Richard Mohs, Michael Statnick,...> ;Neuropsychopharmacology. 2016 Jun 1
13 citations
Inpatient rehabilitation of patients requiring hemodialysis: improving efficiency of care.
George Forrest, Masato Nagao, Anjum Iqbal, Rishi Kakar> ;Archives of Physical Medicine and Rehabilitation. 2005 Oct 1
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Journal Articles

FIRST Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-bl...
Inder Kaul, MD Sharon Sawchak, RN Prof Christoph U Correll, MD Rishi Kakar, MD Prof Alan Breier, MD Haiyuan Zhu, PhD Andrew C Miller, PhD Steven M Paul, MD Stephen K ..., The Lancet, 12/14/2023

Abstracts/Posters

Translational Research with Dexmedetomidine (DM) for the Treatment of Agitation from Healthy Volunteers to Two Patient groups: Those with Schizophrenia or with Probabl...
Sheldon Preskorn , Rishi Kakar , Hrishikesh Kumar , Sameer Sharma† , Vince O’Neill† , Robert Risinger† , Frank Yocca†, American Society of Clinical Psychopharmacology, Scottsdale, AZ, 5/2019
Clinical training in Neurosciences: NIMH perspective
Kakar, R. Akil, M, Pao, M, Journal of Biological Psychiatry, 4/2011

Press Mentions

Human Trials for General Anxiety Disorder Involve LSD CompoundOctober 3rd, 2022
Miami Clinic Kicks off First National Study of LSD, Once a ‘Public Enemy,’ to Treat AnxietySeptember 22nd, 2022
Karuna Therapeutics Scores Phase 3 Win for Schizophrenia Therapy KarXTAugust 9th, 2022
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Research History

Research Fellow, NIMHPsychosomatic fellow/Georgetown Resident2010 - 2011

Hospital Affiliations

Plantation General HospitalFort Lauderdale, Florida
Westside Regional Medical CenterFort Lauderdale, Florida
HCA Florida Aventura HospitalMiami, Florida

Industry Relationships

Speaker/Consultant, Otsuka LUNDBECK2017 - 2020
Coordinating Investigator, Eli LillyCoordinating investigator, medical review 15-MJ- NOAC clinical study2014 - 2014
Consultant, Neurocrine Biosciences2013 - 2014