Comparison of Vitamin B12 Supplementation and SSRI to SSRI Monotherapy in Treating Depression With Low Normal B12: A Randomized Open Label trialComparison of Vitamin B12 Supplementation to SSRI Versus SSRI Antidepressant Treatment Alone
试验速览
- 阶段
- 不适用
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression.
研究概览
简要总结
While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting an open label randomized controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will be allocated to each arm of intervention at out patient clinics of the department of Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.
详细描述
Vitamin B12 plays an important role in DNA synthesis and neurological function. Its deficiency is associated with hematological, neurological and psychiatric manifestations of which the latter include irritability, personality change, depression, dementia and rarely, psychosis. Recent literature has seen links between this vitamin and depression. High B12 levels in serum are associated with good treatment response, high homocysteine levels are common in folate / B12 deficiency and in those suffering from depression. Hyperhomocysteinemia may have direct effects on neurotransmitters implicated in depression.
Randomized trials have shown folate and other nutritional supplementations are strategies of atleast significant effect in treating treatment-resistant depression. Folate deficiency has also been linked with delay in treatment response as well as relapse.
To date no trial from Pakistan compares anti-depressant monotherapy with B12 augmentation in a population showing poor or partial response to first drug trial. The investigators aim to compare clinical response of SSRI-monotherapy with that of B12-augmentation in a sample of depressed patients.
Objective
To compare reduction in depression of patients with low normal B12 levels on SSRI monotherapy with patients on a combination of SSRI and Vitamin B12 supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between ages 18 to 64 years who meet the criteria for a depressive episode as measured by a score of ≥ 16 on first 17 items of HAM-D (Urdu version.
- •Patients with low normal B12 levels in serum (>191 but < 300 pg/ml)
- •Those who will provide informed consent
排除标准
- •Patients with concurrent unstable medical illness
- •History of manic episodes or psychotic illness
- •Psychotic symptoms within depressive episode
结局指标
主要结局
Decline in HAM-D score of 20% or more from baseline indicating improvement in Depression.
时间窗: 03 months
次要结局
未报告次要终点