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临床试验/CTRI/2024/05/067542
CTRI/2024/05/067542已完成4 期

Efficacy and Safety of Fluvoxamine alone and in combination with L-Methyltetrafolate in patients with Obsessive Compulsive Disorder

PT B.D Sharma UHS Rohtak1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年5月19日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
1.Improvement in Y- BOCS scale

研究概览

简要总结

Obsessive-compulsive disorder (OCD) is a disabling condition consisting of bothersome

intrusive thoughts that elicit a feeling of discomfort. The prevalence of OCD is on the rise,

according to current trends the global prevalence ranges from 1.6% to 2.3%.1 The

symptoms in 50% cases often first appear in childhood and adolescent. The average age of

onset is 19.5 years.2 The prevalence in India is approximately 1%3 and roughly 90% of

those with OCD have coexisting psychiatric diagnoses, most commonly are anxiety

disorders.2

OCD is characterized by significant impairment of cognitive-behavioral inhibition, which

is associated with cognitive processes evoking anxiety, along with an increased desire for

perfect control over the possible harm.3

As per International Classification of Diseases (ICD) 11 obsessive compulsive and related

disorders includes olfactory reference syndrome, body dysmorphic disorder, bodily

focused repetitive behaviour disorder, hoarding disorder, hypochondriasis.10

Selective Serotonin Reuptake Inhibitors (SSRIs) along with Exposure and Response

Prevention (ERP) are the cornerstones of treatment for OCD. The initial line of treatment

for OCD is SSRIs like sertraline, paroxetine, fluvoxamine, and fluoxetine.4

Fluvoxamine is effective in treating OCD, and was the first SSRI to be approved for this

use. It blocks reuptake of serotonin at the sodium-dependent serotonin transporter (SERT)

of the neuronal membrane, enhancing actions of serotonin on 5HT1A autoreceptors.7 The

initial daily dose of fluvoxamine is 50 mg and the dose is further increased to100 mg if a

patient shows no improvement after 2 weeks of initiation of treatment. The maximum dose

prescribed is upto 250 mg depending on the improvement.7

Folate plays an important role in carbon transfer metabolism (methylation), required for

the synthesis of serotonin and other monoamine neurotransmitters as well ascatecholamines.5 Low folate levels are associated with mental illnesses like primarily

affective and psychotic disorders.6

In resistant cases of OCD, L-methyl tetrahydrofolate has been evaluated to the augment the

effect of fluvoxamine. However, there is scarcity of data regarding the additional benefit

effect of L- methyl tetrahydrofolate and it will be important to see the effect of

fluvoxamine in OCD patient when L-methyl tetrahydrofolate is used as an augmentation

strategy from the start of treatment. Hence, the current study is planned to assess the

efficacy and safety of fluvoxamine alone and in combination with L- methyl

tetrahydrofolate as add on therapy in patients of OCD

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 years 2)Patient fulfilling the criteria of OCD as per ICD-11 any severity YBOCS score more than
  • Willing to participate and give informed consent.

排除标准

  • Current diagnosis of OCD with psychotic features or any other psychiatric diagnosis in the past 2) Patient with a history of any chronic physical illness 3) Current psychoactive substance use • Pregnant and lactating women.

结局指标

主要结局

1.Improvement in Y- BOCS scale

时间窗: Baseline,2,4,6 and 12 weeks

2. Improvement in CGI scale

时间窗: Baseline,2,4,6 and 12 weeks

次要结局

  • 1.Number of patients who withdrew from study due to ADR’s of drugs.(2. Number of patients requiring augmentation of fluvoxamine therapy)

研究者

发起方
PT B.D Sharma UHS Rohtak
申办方类型
Other [Pt B D Sharma UHS- Government]
责任方
Principal Investigator
主要研究者

Dr Rakesh Mittal

PT B.D. Sharma PGIMS Rohtak

研究点 (1)

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