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Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity (OligoTreat)
EU CTIS ID: 2024-514457-30-00
What this study is testing
The primary objective 1 is the change in Global Assessment of Functioning (GAF) scores from the start of the intervention period (V1.1) to primary outcome visit after 90-93 days of treatment (V2). The primary objective 2 is the change in working memory performance assessed by the n-back test (2-back level, d-prime) from V1.1 to V2.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
- Age between 18 and 65 years
- Total Positive and Negative Syndrome Scale (PANSS) score ≤ 75 at V0
- Stable antipsychotic treatment dose for at least one week prior to inclusion
- Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion
You likely can't join if
- Patients who are unable to give informed consent
- Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction
- Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion
- 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)
- 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)
- Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics
See the full eligibility criteria
- Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
- DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
- Age between 18 and 65 years
- Total Positive and Negative Syndrome Scale (PANSS) score ≤ 75 at V0
- Stable antipsychotic treatment dose for at least one week prior to inclusion
- Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion
- 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
- Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
- 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
- Patients who are unable to give informed consent
- Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction
- Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion
- 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)
- 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)
- Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics
- Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome)
- Current hypokalaemia and/or clinically relevant hyponatraemia at screening
- Patient-reported hereditary galactose-intolerance and/or Lapp lactose-deficiency, lactose intolerance and/or glucose-galactose malabsorption
- Pregnancy or breast-feeding
- 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
- Coercive treatment at the time of study inclusion
- For the optional MRI assessments: potential MRI contraindication(s)
- Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for <30 days
- Insufficient understanding of the German language
- 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
- Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures
- Concomitant use of any other putative remyelinating therapy as determined by investigator
- Co-occurrent unstable somatic condition
- Known porphyria
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.