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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR KETAMINE HYDROCHLORIDE

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Clinical Trials for Ketamine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00054704 Riluzole to Treat Depression in Bipolar Disorder Terminated National Institute of Mental Health (NIMH) Phase 2 This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in Bipolar Disorder. Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients. Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test. Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures: Physical examination and electrocardiogram (EKG) at the beginning and end of the study; Weekly check of vital signs (temperature, blood pressure and heart rate); Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response; Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects. At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Atendemos pacientes de habla hispana. We enroll eligible participants locally and from around the country. Travel arrangements are provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.
NCT00088699 Rapid Antidepressant Effects of Ketamine in Major Depression Recruiting National Institute of Mental Health (NIMH) Phase 1/Phase 2 This study examines whether Ketamine can cause a rapid-next day antidepressant effect in patients with Major Depression/Bipolar Disorder . Purpose: 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.
NCT00115102 Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls Completed Danish Pain Research Center Phase 4 This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.
NCT00115102 Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls Completed University of Aarhus Phase 4 This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ketamine Hydrochloride

Condition Name

Condition Name for Ketamine Hydrochloride
Intervention Trials
Pain 61
Depression 41
Major Depressive Disorder 39
Postoperative Pain 33
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Condition MeSH

Condition MeSH for Ketamine Hydrochloride
Intervention Trials
Depression 118
Depressive Disorder 100
Pain, Postoperative 70
Depressive Disorder, Major 59
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Clinical Trial Locations for Ketamine Hydrochloride

Trials by Country

Trials by Country for Ketamine Hydrochloride
Location Trials
United States 375
France 39
Canada 34
Egypt 31
Israel 20
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Trials by US State

Trials by US State for Ketamine Hydrochloride
Location Trials
New York 59
Connecticut 30
Massachusetts 24
Texas 23
Minnesota 21
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Clinical Trial Progress for Ketamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ketamine Hydrochloride
Clinical Trial Phase Trials
Phase 4 215
Phase 3 69
Phase 2/Phase 3 43
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Clinical Trial Status

Clinical Trial Status for Ketamine Hydrochloride
Clinical Trial Phase Trials
Completed 221
Recruiting 213
Not yet recruiting 86
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Clinical Trial Sponsors for Ketamine Hydrochloride

Sponsor Name

Sponsor Name for Ketamine Hydrochloride
Sponsor Trials
Assiut University 28
Yale University 22
National Institute of Mental Health (NIMH) 21
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Sponsor Type

Sponsor Type for Ketamine Hydrochloride
Sponsor Trials
Other 805
Industry 56
U.S. Fed 30
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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
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Cerilliant
Cipla
McKinsey
QuintilesIMS
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Medtronic

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