Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features
Conditions
Interventions
Intervention1: Ketamine Solution 50 mg/mL PFS: Subjects will receive either Ketamine Solution 50 mg/mL Prefilled Syringe for Subcutaneous Injection at a dose of 0.5 mg/kg of body weight or equivalent
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between 18 to 65 years of age (both inclusive). 2. Subjects of depression who have failed to respond to the treatment with adequate dose and duration (minimum three weeks from initiation of the last antidepressant drug) of at least two different classes of antidepressant medications (TRD), without psychotic features, as assessed by investigator with the Structured Clinical Interview for DSM-5 (Diagnosis of TRD will be made based on patient’s treatment record and clinical interview). 3. Subjects with negative alcohol breath test result and urine screening result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine) [Note: If the patient is taking any of these drugs on prescription may be included in the study in spite of a positive screening results for the prescribed drug(s)]. 4. Subjects with baseline score of = 22 on the Montgomery and Åsberg Depression Rating Scale (MADRS). 5. Subjects with baseline score of = 9 on Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), 6. For Female Subjects, of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, a double-barrier method, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year. OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject). 7. Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom IEC/IRB approved written informed consent has been obtained prior to screening. 8. Subjects shall be willing and able to understand and comply with the requirements of the protocol, administer the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
Exclusion criteria
Exclusion criteria: 1. History of previous non-response to esketamine or ketamine in depressive episode. 2. Subjects having any unstable medical or neurological condition as per principal investigator assessment. 3. Subject has suicidal ideation with intent to act during screening phase or on Day 1 (prior to randomization) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) or per Investigator"s clinical judgment, or has a history of suicidal behaviour within the past year as assessed on the C SSRS; or subject has homicidal ideation/intent at Screening or on Day 1. 4. Subjects with substance abuse or dependence in the 6 months prior to screening. 5. Subjects with any psychotic disorder, bipolar disorder, obsessive compulsive disorder, intellectual disability, autism, cluster B personality disorder, organic disorder, developmental disorder. 6. Subjects with lifetime abuse or dependence on ketamine. 7. Subjects with previous history of non-response to Ketamine, or to all of the oral antidepressant medications. 8. Subjects with history of Vagus Nerve Stimulation (VNS) or deep brain stimulation in current episode of depression. 9. Subjects with history of homicidal ideation/intent. 10. Subjects with QT prolongation =450 msec during screening ECG or other significant arrhythmias. 11. Subjects with Other major medical conditions including coronary artery disease, uncontrolled hypertension, hypertensive crisis. 12. Subjects with known case of HIV infection, Hepatitis B, or Hepatitis C Infection. 13. Subjects with known case of Type 1 diabetes or Type 2 diabetes mellitus with HbA1c value greater than 8%. 14. Subjects who have any condition that would compromise compliance with this protocol. 15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 16. Female subjects who are not ready to use acceptable contraceptive methods during the study period. 17. Suspected hypersensitivity to Ketamine or any of the ingredients of the formulation. 18. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results. 19. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry. 20. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 21. Suspected inability or unwillingness to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of responders in the test group compared to that in placebo group as assessed by MADRSTimepoint: Subjects in the Test product arm will receive Ketamine Solution 50 mg/mL PFS for Subcutaneous Injection at a dose of 0.5 mg/kg of body weight upto twice a week (on day 1 & day 4) for up to 6 weeks. Subjects in the Reference product arm will receive Matching Placebo of Ketamine solution upto twice a week (on day 1 & day 4) for up to 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| change in depression severity from baseline to study endpoint using MADRS in test group versus placebo, Change from baseline to study endpoint in the Patient Health Questionnaire (PHQ-9) score. Change from baseline to study endpoint in Clinical Global Impression (CGI) Scale Remission from depression (at end of treatment period), defined as the proportion of participants who had a depression rating of less than or equal to ten on the MADRS. Number of doses to Clinically Relevant Response (= 50% on MADRS) Number of doses to show at least 25% improvement on MADRS Change in C-SSRS (Columbia-Suicide Severity Rating Scale) score from baseline to end of treatment Change from baseline to study endpoint in Brief Psychiatric Rating Scale (BPRS) to assess the Psychotomimetic effects during the study using Brief Psychiatric Rating Scale (BPRS) Timepoint: Subjects in the Test product arm will receive Ketamine Solution 50 mg/mL PFS for Subcutaneous Injection at a dose of 0.5 mg/kg of body weight upto twice a week (on day 1 & day 4) for up to 6 weeks. Subjects in the Reference product arm will receive Matching Placebo of Ketamine solution upto twice a week (on day 1 & day 4) for up to 6 weeks | — |
Countries
India
Contacts
Public ContactSangameshwar Iyer
Biosite Research Private Limited.
Outcome results
None listed