EUCTR2010-020140-36-SK进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups ofTC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patientswith Major Depressive Disorder Who Exhibit an Inadequate Response toAntidepressant Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of signed and dated informed consent before initiation of any studyrelated
- •procedures.
- •2. Patients must provide acceptable proof of identity documentation to confirm initials
- •and date of birth.
- •3. Male or female patients aged 18-65 years, inclusive:
- •Male patients: Male patients who are sexually active must use a double
- •barrier method of contraception (condom with spermicide) from the first dose
- •of IP until 12 weeks after their last dose.
- •Women of childbearing potential: Women of child-bearing potential
- •(WOCBP) must have a negative urine pregnancy test and confirmed (by the
- •investigator) use of a highly effective form of birth control for 3 months before
- •enrollment and until 3 months after their last dose of IP. The following
- •methods of highly effective birth control include the birth control option plus
- •the use of a condom by the male sexual partner: vasectomized sexual partner,
- •tubal occlusion, intrauterine device (IUD [copper banded coils only]),
- •intrauterine system (eg, Mirena), Depo-Provera, implants (Implanon, Norplant), normal and low dose combined oral pills, ethinylestradiol
- •transdermal system (Evra Patch), and intravaginal device (NuvaRing). Highly
- •effective birth control can also include true sexual abstinence (starting at the
- •screening visit and through completion of the study). The investigator will
- •assess the method of birth control and compliance at each study visit.
- •Women of non-child-bearing potential. Women of non child-bearing
- •potential are defined as women who are either permanently sterilized
- •(hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but
- •excluding bilateral tubal occlusion) or who are postmenopausal. Women will
- •be considered postmenopausal if they are amenorrheic for 12 months without
- •an alternative medical cause. The following age-specific requirements apply:
- •Women under 50 years old would be considered post menopausal if they
- •have been amenorrheic for 12 months or more following cessation of
- •exogenous hormonal treatment and luteinizing hormone (LH) and
- •follicle stimulating hormone (FSH) levels in the post-menopausal range.
- •Women over 50 years of age would be considered postmenopausal if
- •they have been amenorrheic for 12 months or more following cessation
- •of all exogenous hormonal treatment.
- •4. Primary clinical diagnosis meeting criteria from the DSM-IV-TR:
- •296.2x Major Depressive Disorder (MDD), Single Episode, Unspecified or
- •296.3x Major Depressive Disorder (MDD), Recurrent, Unspecified
- •as confirmed via the Mini International Neuropsychiatric Interview (MINI)
- •version.6.0 diagnostic scale.
- •5. History during current depressive episode of an inadequate response to no more
- •than one antidepressant (SSRI/SNRI) as assessed by a review of the patients history
- •(ATHF). Patients who are not currently receiving treatment with antidepressant
- •drugs during this current depressive episode are allowed.
- •6. Documented HAMD-17 as follows:
- •- Screening (Visit 1) and open-label baseline (Visit 2): Clinician-rated total
- •score =20.
- •- Randomization (Week 8/Visit 6): Clinician rated =16 total score and a <50%
- •reduction in total score compared to open-label baseline (Visit 2).
- •7. Have a HAMD-17 score =2 on item 1 (depressed mood) at screening (Visit 1) and
- •open-label baseline (Visit 2).
- •8. Documented CGI-S as follows:
- 另有 3 项未显示
排除标准
- •1. Patients with: a) lifetime history of bipolar disorder and/or psychotic disorder; MDD
- •with psychotic features is excluded; b) current (within 12 months before open-label
- •baseline [Visit 2]) manic episode, post-traumatic stress disorder as assessed by the
- •MINI 6.0 and confirmed by the investigator; c) current (within 12 months before
- •open-label baseline [Visit 2]) generalized anxiety disorder, panic disorder, obsessive
- •compulsive disorder or social anxiety disorder as assessed by the MINI 6.0, and
- •considered by the investigator to be primary (causing a higher degree of distress or
- •impairment than MDD).
- •2. Patients with a diagnosis of DSM-IV-TR Axis II disorder which has a major impact
- •on the patient’s current psychiatric status.
- •3. Patients whose current episode of depression started less than 8 weeks before
- •4. History of hypersensitivity or intolerance to drugs with a similar chemical structure
- •or class to TC-5214.
- •5. Substance or alcohol abuse or dependence within 6 months prior to enrollment, as defined in DSM-IV-TR criteria. Patients with a positive urine toxicology screen will be excluded, with the exception of patients testing positive for cannabinoids.
- •6. Subjects with a history of suicide attempts in the past year and/or seen by the
- •investigator as having a significant history of risk of suicide or homicide, or
- •considered at risk for suicide or homicide during the study. Also patients who have
- •a HAMD-17 item 3 score of =3.
- •7. Presence of renal insufficiency as evidenced by creatinine clearance of =50 mL/min
- •8. Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
- •9. Positive test results for human immunodeficiency virus antibody.
- •10. History of renal insufficiency or impairment or conditions that could affect
- •absorption or metabolism of investigational product
- •11. Patients on thyroid medication unless at a stable dose for =3 months; thyroid level must be within normal range.
- •12. A diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in
- •remission for at least 5 years.
- •13. Any other severe progressive or uncontrolled medical condition, or chronic medical illness.
- •14. Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
- •15. Evidence of uncontrolled diabetes mellitus as judged by the investigator or exhibited by hemoglobin A1c >8%.
- •16. Alanine aminotransferase or asparate aminotransferase =3.0 times the upper limit of normal and total bilirubin 1.2 times the ULN.
- •17. History of severe medication allergy/hypersensitivity or ongoing medication
- •allergy/hypersensitivity
- •18. History of stroke or transient ischemic attack.
- •19. Myocardial infarction within 180 days before screening (Visit 1).
- •20. History of seizures or seizure disorder (single infant febrile seizure with full
- •recovery is acceptable).
- •21. History of head trauma, including closed head injury, in which loss of consciousness occurred.
- •22. Receipt of electroconvulsive therapy within the last 2 years.
- •23. Use of prohibited treatments.
- •24. Patients who, in the investigator’s opinion, will require any form of psychotherapy
- •during the study period, unless psychotherapy has been ongoing for a minimum of
- •3 months prior to study start.
- •25. Pregnancy or lactation.
- •26. Clinically significant deviation from the reference range in clinical laboratory test
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