EUCTR2016-004023-24-DK进行中（未招募）1 期
Effect of erythropoietin (EPO) on cognitive function and frontal lobe activity in patients with bipolar disorder and unipolar depression in remission (PRETEC-EPO)
Copenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet0 个研究点目标入组 75 人开始时间: 2016年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with bipolar disorder or unipolar depression in remission:
- •Bipolar disorder or unipolar depression confirmed with Schedules for Clinical Assessment in Neuropsychiatry (SCAN)-interview
- •18-65 years of age
- •Score <=14 on Hamilton Depression Rating Scale 17 items (HDRS-17) and Young Mania Rating Scale (YMRS)
- •Cognitive difficulties assessed with the Danish version of the Screen for Cognitive Impairment in Psychiatry (SCIP), defined as a summed score of <=77 or score below cutoff on at least 2/5 subtests (list learning <=21, consonant trigramme task <=18, verbal fluency <=14, delayed list recall <=6, and visuomotor task <=10) on the SCIP-D (Jensen et al., 2015; Purdon, 2005) at the time of inclusion. Cutoff-scores are determined for each subtest in Jensen et al. (2015).
- •Participants must have adequate levels of Danish language skills to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previous EPO-treatment
- •Drug abuse or addiction (including alcohol and benzodiazepines corresponding to >22.5 mg. alopam per day)
- •Kidney disease
- •Pregnancy or breast feeding
- •Women, who use the contraceptive pill or other hormonal contraceptives (not including hormonal coil) and do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
- •Sexually active women in the fertile age, who do not or do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
- •Previous head trauma
- •Neurological illness
- •Heart diseases (previously diagnosed or abnormal EKG findings during screening)
- •Previous or current epilepsy in the participants or his/her first degree family
- •Previous or current tromboembolic events or tromboses in first degree family occured before the age of 60 (because of increased tromboembolic risk)
- •Contraindications against profylactic trombosis treatment
- •Myeloproliferative disorder, polycythemia
- •Obesity (BMI > 30) or a body weight of <45 kg or >95 kg
- •Major surgical treatment within 4 weeks before inclusion in the study
- •Known allergy to or antibodies against EPO
- •Previous or current cancer disease
- •Untreated or insufficiently treated hypertension (therapy resistant hypertension defined as a blood pressure over 140/90 mmHg; mean of 3 measures with 2 minute interval morning/midday and evening for three days)
- •Baseline hematocrit value >50% for men and >48% for women
- •Thrombocyte numbers over normal (>400 billions/L)
- •Reticulocyte numbers ERC(B), below 1*10^-3
- •Reluctance or inability to comply with the protocol requirements, including the presence of any condition (physical, mental or social), which is likely to affect the participant's ability to comply with the protocol
- •Current somatic disease, which is evaluated as being of importance for patient participation
- •Electroconvulsive (ECT) treatment within the last 3 months
- •Claustrophobia
- •Pacemaker or metal implantate in the body
- •Insufficient Danish language skills
研究者
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