Ketamine Treatment Options in Texas

Suicidal ideation (SI) associated with major and bipolar depression is commonly seen in a wide range of clinical practice situations including the emergency room (ER). Current treatment regimens are often unsatisfactory. About a third of patients fail to respond to currently available therapy, and there are no currently FDA indicated rapid acting treatments for SI. Suboptimal outcomes have triggered the search for new, well-tolerated and more effective forms of treatment. Small clinical trials suggest that low dose (0.5mg/kg) ketamine is safe and effective for SI. We believe adding music during ketamine infusion may reduce anxiety and lead to more reduced SI based on available evidence. We are testing the hypothesis that a single infusion of ketamine combined with music enhances tolerability and improves outcomes in the treatment of SI when combined with treatment as usual in a factorial study design. One treatment with Ketamine + music will be compared to compared to one-time treatment with ketamine alone, music alone, or treatment as usual. 50 individuals with a depressive episode and suicidal ideation will receive intravenous (IV) ketamine 0.5mg/kg infused over 40 minutes once with 60 minutes of music, 50 individuals will receive IV ketamine without music, 50 subjects will receive 60 minutes of music once, and 50 patients will receive treatment as usual without ketamine or music. We anticipate that the ketamine + music group will have statistically significant indices of improvement in the primary outcome, suicidal ideation scores on the Scale for Suicidal Ideation (SSI) 4 weeks after the ketamine infusion. Secondary outcomes will include depression scores on the MontgomeryÅsberg Depression Rating Scale (MADRS) scale, adverse effects, and SSI scores at the end of 4 weeks. If, as we anticipate, the results indicate success of ketamine + music for SI, the work will identify new opportunities to more effectively manage patients with depression and suicidal ideation presenting to the ER. Read Less

NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes. Read Less

This is an observational study to assess the change in several psychological screening tools before and after a series of six ketamine infusions in paramedics who suffer from post traumatic stress disorder as a result of working in emergency medical services. Read Less

Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers Read Less

A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers Read Less

The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine (LDK) to the industry standard of morphine (MOR) in regards to controlling acute pain in the emergency department. Both LDK and morphine have side effects. The amount and character of these side effects will be compared. Additionally, the degree of sedation or agitation will be specifically measured. The aim of this current study is to make this comparison and shift the evidence for LDK use from the anecdotal to the scientific. Read Less

The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control using morphine when treating abdominal pain. Read Less

The primary objective of this study is to determine the effectiveness of serial infusions of intravenous (IV) ketamine in adults with treatment resistant depression (TRD). Read Less

We will be investigating the use of ketamine in sedation for endoscopic procedures, specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy. Participants will be randomized to one of two arms including conventional moderate sedation with midazolam and fentanyl or the ketamine arm. They will then undergo the planned procedure. Physicians preforming the procedure will be surveyed following the procedure and patients will be surveyed twice, once after meeting criteria for discharge on day of the procedure and a second time 48 hours following the procedure. Read Less

Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Three factors may contribute to the development of persistent, post-amputation PLP by inducing central sensitization at different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute postoperative pain (5-7). Investigators hypothesis that pre-amputation period could be important in eliminating Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The reduction of pre-operative pain and prevention of formation of pain memories may eliminate development of PLP by using dual networks treatment strategy. This Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing lower limb amputation. Read Less

Klarisana is conducting an observational study in San Antonio, Texas to see if there are tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat veterans after receiving a series of six low-dose outpatient infusions of ketamine. Read Less

This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them. Read Less