CTRI/2012/07/002773Other2 期
A Multicenter, Double-Blind, 58 week Rollover Study to assess the Safety and Tolerability ofBMS-820836 in Patients with Treatment Resistant Major Depression
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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) < 50% decrease in HAMD-17 total score from the parent study
- •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
- •(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
排除标准
- •Exclusion Criteria
- •1) Target Disease Exceptions
- •a) Subjects must have met all Target Disease criteria for protocol CN162006 or
- •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
- •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.
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