NCT07645807尚未招募不适用
An Investigator-Initiated, Randomized, Double-Blind, Double-Dummy Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy Endpoints
研究概览
简要总结
To evaluate the efficacy of adjunctive CreNeuroSTM CNS Fish Oil Plus Softgels in patients with Major Depressive Disorder receiving escitalopram.
详细描述
The study population will include patients with moderate to severe Major Depressive Disorder who are either treatment-naïve or have discontinued prior antidepressant therapy following an appropriate washout period prior to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male or female subjects aged between 18 and 65 years, inclusive.
- •Subjects with a clinical diagnosis of Major Depressive Disorder (MDD) as determined by the investigator or qualified psychiatrist, based on standard clinical judgment.
- •Subjects with moderate to severe depression, defined as a Hamilton Depression Rating Scale (HAM-D-17) score ≥18 at both screening and baseline visits.
- •Subjects who are either:
- •Planned to initiate treatment with escitalopram, or
- •Have already started escitalopram therapy within ≤2 weeks prior to screening, provided that any prior antidepressant therapy was discontinued with an adequate washout period (≥2 weeks or ≥5 half-lives of the previous medication, whichever is longer) before baseline assessment.
- •Subjects who are medically stable, as assessed by the investigator based on medical history, physical examination, and any relevant laboratory investigations.
- •Subjects who are able and willing to provide written informed consent prior to participation in the study.
- •Subjects who are willing and able to comply with study procedures, treatment regimen, and scheduled study visits.
排除标准
- •High suicide risk, defined as:
- •Presence of active suicidal ideation with intent or plan, or
- •Subject considered by the investigator to be at significant risk of suicide.
- •History of suicide attempt or self-harm
- •Presence of major psychiatric disorders other than MDD, including but not limited to:
- •Bipolar disorder
- •Schizophrenia or other psychotic disorders
- •Presence of severe or unstable medical conditions that may interfere with study participation or pose a risk to the subject, including but not limited to:
- •Uncontrolled hepatic (liver) disease
- •Significant renal (kidney) impairment
- •Clinically significant cardiovascular disease
- •Known hypersensitivity or allergy to:
- •Escitalopram
- •Fish oil or omega-3 fatty acid or folic acid, or L-5-methyltetrahydrofolate supplements
- •Pregnant or lactating women, or women planning to become pregnant during the study period.
- •Use of concomitant medications or treatments that may confound study outcomes, including:
- •Other antidepressants (unless in the process of being switched to escitalopram)
- •use of omega-3 or fish oil or folic acid, or L-5-methyltetrahydrofolate supplements
- •Any condition or circumstance which, in the opinion of the investigator, may compromise subject safety, adherence to study procedures, or the integrity of study data.
- •History of substance abuse within 6 months prior to screening.
- •Prior treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the current depressive episode.
- •Initiation of new psychotherapy or change in psychotherapy intensity within 8 weeks prior to screening.
- •Participation in other interventional or non-interventional studies within 3 months prior to screening.
- •High dietary intake of fish (≥3 times per week) or use of fish oil/n-3 PUFA/folate supplements within the past 6 months.
- •Moderate to severe anxiety disorders, as assessed by GAD-
- •Participation in another clinical study within 30 days.
研究组 & 干预措施
Test Arm
Experimental
CreNeuroSTM CNS Fish Oil Plus Softgels
干预措施: 1. Escitalopram (as escitalopram oxalate) tablet 2. CreNeuroSTM CNS Fish Oil Plus Softgels (Combination Product)
Control Arm
Placebo Comparator
Placebo softgels
干预措施: 1. Escitalopram (as escitalopram oxalate) tablet 2. Placebo softgels (Combination Product)
结局指标
主要结局
Efficacy Endpoints
时间窗: Baseline, Week 2, Week 4, Week 6 and week 8
Change in HAM-D-17 (Hamilton Depression Rating Scale - 17 items) total score from baseline to Week 2, Week 4, Week 6 and week 8. Score range (0 - 52): Higher scores indicate greater severity of depression, while lower score indicate improvement in depressive symptoms.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use DisorderCannabis WithdrawalNCT07644052PleoPharma, Inc.420
尚未招募
3 期
Assessment of the safety and effectiveness of tDCS as an add-on therapy for managing upper limb spasticity after stroke: a randomized controlled trialCTRI/2026/02/103047Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)52
尚未招募
1 期
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis BNCT07589400Xiamen Amoytop Biotech Co., Ltd.24
撤回
3 期
A Study Providing Continued Access to Treatment in Patients with a Neurological Disease Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and without Access to A Post Trial Access Program2023-507633-21-00F. Hoffmann-La Roche AG196
招募中
3 期
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Early Onset Alzheimer's Disease Caused by a Genetic Mutation2024-515198-91-00Washington University School Of Medicine24