PER-035-20招募中未知
TERAPIA CON LASER TRANSCRANEAL INFRARROJO CERCANO EN SUJETOS CON TRASTORNO DEPRESIVO MAYOR: UN ESTUDIO DE DOSIFICACION CON LASER
iteCure LLC.,0 个研究点目标入组 0 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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.Subjects age at screening will be between 18 and 75 years old (inclusive).
- •2.Diagnosis of major depressive disorder (MINI)
- •3.QIDS-C ≥ 12 at screen
- •4.CGI-S ≥ 4 or higher, i.e., moderately depressed”
- •5.Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
- •6.Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
- •7.The subject is willing to participate in this study for at least 12 weeks.
- •8.Subjects will need to be on stable dose(s) of antidepressants (if taking any) for at least six weeks prior to enrollment.
排除标准
- •1.Decrease in SDQ self-report from screen to baseline >=30%, computed as [(SDQscreen-88) – (SDQbaseline-88) / (SDQscreen-88)] >=30/100. A score of 88 is normal” at SDQ.
- •2.The subject is pregnant or lactating.
- •3.The subject failed more than 2 adequate treatment with FDA-approved antidepressants during current episode - less than 50% decrease in depressive symptomatology.
- •4.Structured psychotherapy focused on treating the subject’s depression (i.e. CBT or IPT) is permitted if started at least 8 weeks prior to the screening visit.
- •5.Substance dependence or abuse in the past 3 months.
- •6.History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment).
- •7.Bipolar affective disorder (per MINI assessment).
- •8.Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension).
- •9.Active suicidal or homicidal ideation (both intention and plan are present), as determined by C-SSRS screening.
- •10.The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject’s scalp that is found to be in proximity to any of the procedure sites.
- •11.The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt – Hakim valve).
- •12.Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) – for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) – for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) – for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)
- •13.Recent history of stroke (90 days).
- •14.The subject failed a device-based intervention FDA-approved for the treatment of depression, during the current episode (e.g. less than 50% decrease in depressive symptomatology with TMS, ECT or VNS).
研究者
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