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临床试验/CTRI/2024/01/061652
CTRI/2024/01/061652
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不适用

A Study Of Neurocognitive Side Effects Of Ketamine Versus Electroconvulsive Therapy In Patients With Major Depressive Disorder- A Comparative Study

Department of Psychiatry Sion hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月24日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Department of Psychiatry Sion hospital
入组人数
70
试验地点
1
主要终点
ECT Has More Neurocognitive Side Effects Than Ketamine

概览

简要总结

ECT in depression –

Currently, there are two main treatments to fight depression, antidepressants and psychotherapy, while a third approach, electroconvulsive therapy (ECT), is regarded as a second- or third-line therapy that is usually resorted to in cases where medication and psychotherapy have failed (Kellner et al., 2016b; Karayagmurlu et al., 2019). However, most patients who were resistant to antidepressant or psychotherapy showed improvement after ECT was introduced. In other words, ECT may have a greater effect than the two routinely used methods in fighting depression

Cognitive decline was noted in some depressed patients who received ECT (Brus et al., 2017), and recovery from this declination was suggested to take half a year (Nuninga et al., 2018). However, whether ECT contributed more memory loss than pharmaceutical treatment is still in dispute, but the majority support the view of no additional cognitive damage ascribable to ECT than antidepressants (Husain et al., 2004; Kellner et al., 2016a, b; Bjoerke-Bertheussen et al., 2018). Nonetheless, some studies found no dementia in individuals who underwent ECT (Osler et al., 2018), and in geriatric depressed patients, ECT even improved cognitive function (Socci et al., 2018).

With respect to other common side effects that occurred during ECT treatment, headache and nausea/vomiting are believed to be the most common complaints (Kellner et al., 2006; Karayagmurlu et al., 2019). Thankfully, in the view of severity and prevalence, the ECT recipients reported less headache and nausea/vomiting in recent studies (Husain et al., 2004; McCall et al., 2018; Socci et al., 2018).

Ketamine in depression –

Recent studies are accepting the role of glutamate in depression, in particular NMDA receptors along with serotonin receptors. While conventional pharmacotherapy usually takes several weeks (usually 4-12 weeks) to improve symptoms, Ketamine is an N-methyl-D aspartate receptor antagonist having rapid action on depressive symptoms.

Regardless of the ketamine form, patients commonly experience dissociative adverse effects, such as psychosis-like conditions. In addition to the dissociative side effects of ketamine therapy, there are also physiological effects. For example, roughly 40% of people given a single dose of IV ketamine have increased heart rate and blood pressure for a limited time after treatment. Patients have also experienced symptoms including anxiety, blurred vision, dizziness, headache, nausea, or vomiting with the use of ketamine.

Eriksson notes that the peak concentration of oral ketamine is much lower than that of IV ketamine. Since ketamine’s action on NMDA receptors causes dissociative side effects, clinicians believe a lower peak dosage has improved tolerability.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients above 18 years of age.
  • Patients diagnosed with MDD and not better with medications.
  • Patients requiring ECT.

排除标准

  • Patient not willing to give consent.
  • Pregnant and Lactating woman.
  • Patients having contraindications for ECT and Ketamine.
  • Patients with comorbid substance use except Nicotine.
  • Patients who have received either ECT or ketamine during the past 6 months.
  • Patients with a history of non-responsiveness to ECT or ketamine.
  • Patients with any condition that is known to be associated with cognitive impairment.

结局指标

主要结局

ECT Has More Neurocognitive Side Effects Than Ketamine

时间窗: Baseline, 1 Week Post Treatment Endpoint, 1 Month Post Treatment Endpoint

次要结局

  • To Check How Much Less Neurocognitive Side Effects Does Ketamine Have As Compared To ECT(Baseline, 1 Week Post Treatment Endpoint, 1 Month Post Treatment Endpoint)

研究者

发起方
Department of Psychiatry Sion hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Heli Yogesh Shah

Lokmanya Tilak Municipal Medical College And General Hospital

研究点 (1)

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