EUCTR2022-000054-28-DE进行中（未招募）1 期
Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity (OligoTreat) - OligoTreat
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1.Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- •2. DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
- •3.Age between 18 and 65 years
- •4.Total Positive and Negative Syndrome Scale (PANSS) score = 75 at V0
- •5.Stable antipsychotic treatment dose for at least one week prior to inclusion
- •6.Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion
- •7.Female participants with reproductive potential must have a negative beta-HCG serum pregnancy test using a pregnancy test strip as part of the screening visit
- •8.Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
- •9.Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Patients who are unable to give informed consent
- •2.Coercive treatment at the time of study inclusion
- •3.Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for <30 days
- •4.Insufficient understanding of the German language
- •5.Patients with primary active (moderate or severe) substance use disorder (other than nicotine) according to MINI interview (DSM-V): patients fulfilling early (>3 months) or sustained (>12 months) remission criteria and/or with low severity of substance use disorder according to MINI are eligible for the study
- •6.Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures
- •7.Concomitant use of any other putative remyelinating therapy as determined by investigator
- •8.Co-occurrent unstable somatic condition
- •9.Known porphyria
- •10.Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction
- •11.Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion
- •12.Known intolerance, allergy/contraindications to one of the study drugs or any of the excipients or other agents with similar chemical properties as the study drugs (such as other arylalkylamine antihistamines)
- •13.Clinically relevant liver and/or renal impairment (serum creatinine >1.5mg/dl or eGFR<30 ml/min/1.73 m2 at screening, AST or ALT > 2-times the upper limit of normal at screening)
- •14.Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics
- •15.Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome)
- •16.Current hypokalaemia and/or clinically relevant hyponatraemia at screening
- •17.Patient-reported hereditary galactose-intolerance and/or Lapp lactose-deficiency, lactose intolerance and/or glucose-galactose malabsorption
- •18.Pregnancy or breast-feeding
- •19.Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.
- •20.For the optional MRI assessments: potential MRI contraindication(s)
研究者
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