CTRI/2022/08/044586已完成3 期
Efficacy of Divalproex plus lamotrigine versus Divalproex plus Aripiprazole in patients of Mixed Depression as per Koukopoulos Diagnostic Criteria A comparative study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1-Both males and females aged 18-65 years.
- •2-Primary diagnosis of Depression with mixed features based on Koukopolous
- •diagnostic criteria.
- •3-Diagnosis of mild-severe Depression with mixed features defined by KMDRS
- •score 10-21.
- •4-Ability to remain on adequate stable regimen (on & off label treatment) for
- •5-Medically stable for study participation.
- •6-Participants who will give voluntary informed consent.
排除标准
- •1-History of chronic psychosis or drug induced psychosis of any kind.
- •2-Currently, DSM-5 diagnosis of drug abuse/dependence in the last six
- •months and has a negative drug screen at baseline.
- •3-Women will be excluded if they are pregnant, lactating or neither surgically sterile nor using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial.
- •History of seizures, renal insufficiency or congestive heart failure.
- •4- History of clinically significant violence.
- •5- History of hypersenstivity/rash/bronchial asthma.
- •6-Current alcohol abuse or dependence.
- •7-Untreated hypertension (Systolic B.P >130mmHg and/or Diastolic B.P >80mm
- •8-Clinically, abnormal liver function tests (LFTs), thyroid, renal function or
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