Efficacy and Safety of Fluvoxamine alone and in combination with L-Methyltetrafolate in patients with Obsessive Compulsive Disorder
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
Dr Rakesh Mittal
PT B.D. Sharma PGIMS Rohtak
