Health Condition 1: null- Treatment Resistant Depression
Conditions
Interventions
Intervention1: BMS-820836: Oral, 0.50 mg , Once a day , tablet , 54 weeks
Intervention2: BMS-820836: Oral, 1.0 mg , once a day , tablet , 54 weeks
Intervention3: BMS-820836: oral , 2 mg , once a day ,
Sponsors
Bristol Myers Squibb India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) Subjects, 18 - 65 years (at entry of the parent study: CN162006 or CN162007), able to give informed consent, and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol required procedures. 2) Target Population b) Subjects must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use. c) Subjects must meet 1 of the following criteria: i) Subjects must have been randomized in and completed the parent study protocol CN162006 (Week 14 Visit) or CN162007 (Week 13 Visit) or ii) Subjects must have been parent study Phase B responders in CN162006 or CN162007 (ie, were not randomized in parent study and have completed the parent study and met the following criteria for inadequate response at the parent study Final Visit of Phase C). Non-response is defined as either: (1) At the completion of Phase C of the parent study the subject meets all 3 criteria below: (a) Phase B Baseline Visit to the final visit of CN162006/CN162007 and (b) HAMD-17 total score >= 16 at the Final Visit of CN162006/CN162007 and (c) A CGI improvement score >= 3 at the last 2 scheduled visits of CN162006/CN162007. OR (2) At the Final Visit of Phase C of CN162006 or CN162007 the subject has a HAMD-17 total score >= 14, and demonstrates >= 25% worsening of their HAMD-17 score compared with the score at the end of the Phase B in the parent study. 3) Age and Reproductive Status a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 30 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP. The requisite drug interaction studies to determine the interaction of BMS-820836 with oral contraceptives have not been performed to date. It is therefore not possible to determine the efficacy of oral contraceptives as an effective method of contraception for WOCBP who participate in this study. Oral estrogen and progestin hormonal contraceptives as a sole method of contraception are therefore prohibited. It is recommended that all WOCBP use 2 methods of contraception for the duration of the study ie, from the start of treatment phase to 30 days after the last dose of study drug. The 2 methods should include 1 barrier method (for eg, condom with spermicidal gel, intrauterine devices, cervical cap, etc) and 1 other method which could include oral contraceptives. b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Women must not be breastfeeding. d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Target Disease Exceptions a) Subjects must have met all Target Disease criteria for protocol CN162006 or CN162007. 2) Medical History and Concurrent Diseases a) Subjects who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history, or routine psychiatric status exam. 3) Physical and Laboratory Test Findings a) Subjects should be excluded if they have an abnormal laboratory test result, vital sign result, or ECG finding that in the investigators judgment is medically significant, in that it would impact the safety of the subject or the interpretation of the study results. 4) Sex and Reproductive Status a) Women of childbearing potential (WOCBP) and men not using an acceptable method of contraception to avoid pregnancy throughout the study and up to 30 days after the last dose of investigational product. b) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Women must not be breastfeeding. 5) Prohibited and Restricted Medications a) Monoamine oxidase inhibitors (MAOIs) (eg, Nardil [phenelzine], selegeline, rasagiline, etc) treatment; b) Antidepressant agents including SSRIs, SNRIs, tricyclic antidepressants, norepinephrine reuptake inhibitors. c) Stimulants used for the treatment of depression such as Provigil® (modafinil). d) Herbal over-the-counter preparations or supplements such as hypericum perforatum (St. Johnâ??s Wort), omega-3 fatty acids, S-adenosyl methionine (SAM e) or kava extracts. e) Any other psychotropic medications such as but not limited to the following: antipsychotics, antiepileptics (including Neurontin® [gabapentin], Lamictal® [lamotrigine], Depakote® [divalproic acid], Depakene® [valproic acid], Tegretol® [carbamazepine]), lithium, anxiolytics (including benzodiazepines, if not on a stable dose, Buspar® [buspirone]) and diphenhydramine. f) Moderate to Potent CYP3A inhibitors (such as but not limited to ketoconazole, itraconazole, fluconazole, nefazodone, HIV protease inhibitors such as atazanavir and ritonavir, clarithromycin, diltiazem, erythromycin amongst others) or inducers (such as but not limited to rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, modafinil amongst others) during the remainder of the study. g) Potent CYP1A2 inhibitors (such as but not limited to ciprofloxacin, clinafloxacin, enoxacin amongst others) are prohibited during the study. h) Subjects who would be likely to require prohibited concomitant therapy during the trial. 6) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness c) Subjects who during the course of their participation in either Study CN162006 or CN162007 were treated in violation of the protocol. Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the long term effect of 3 target doses of BMS-820836 (0.5, 1, and 2 mg/day) through 54 weeks of follow-up in the change from randomization baseline in mean seated blood pressure in subjects with Treatment Resistant Depression.Timepoint: At Weeks 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 56, | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the long term safety and tolerability of 3 target doses of BMS-820836 (0.5, 1, or 2 mg/day) in the treatment of subjects with TRD from randomization baseline through 54 weeks of the Rollover study as measured by the frequency and severity of AEs, frequency of SAEs and discontinuations due to AEs.Timepoint: at Weeks 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 56, | — |
Countries
Argentina, Australia, Austria, Canada, Finland, France, India, South Africa, Spain, Sweden, United States of America
Contacts
Public ContactMrs Subashri Shivkumar
Bristol Myers Squibb India Pvt Ltd.
Outcome results
None listed