Carnosine and Cognitive Training in Schizophrenia

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind placebo-controlled trial to evaluate the effects of the combination of a cognition enhancing drug, i.e carnosine, with cognitive training in patients with schizophrenia. All participants will receive the same cognitive training sessions and will be randomised to either carnosine or placebo for the duration of the combined treatment period (2 weeks). Before combined training and carnosine/placebo, there is a two-week carnosine/placebo only phase to examine the effects of carnosine alone on functioning without training.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abraham Reichenberg; Avraham Reichenberg
• Collaborator: Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• Age 18-60, males and females.

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder documented in a medical record, confirmation by treating physician and/or treatment team, or confirmation of diagnosis by our study psychiatrist or clinical psychologist

• Duration of illness equal to or greater than one year.

• Patients should be clinically stable in a non-acute phase for at least 8 weeks prior to the screening visit

• Treatment with stable doses of antipsychotic medications for at least 4 weeks prior to the screening visit.

• Negative result in the urine pregnancy test performed during the screening visit in women of child bearing potential (not surgically sterile or 2 years postmenopausal).Women of child-bearing potential, who are sexually active, will be considered as potential participants if they are using acceptable methods of contraception, which include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected).

• Subjects must read and write in English at a level sufficient to understand and complete study- related procedures.

• Informed consent signed by participant

Exclusion Criteria:

• DSM -IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV]diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit.

• Current treatment (within 4 weeks) with psychotropic agents known to effect cognition:

amphetamines, barbiturates, MAOIs, methylphenidate, benzodiazepines.

• Pregnant or breast-feeding women.

• Clinically significant abnormalities on physical examination.

• History of a serious neurological disorder or a systemic illness with known neurological complications.

• History of significant other major or unstable metabolic, hepatic, renal, hematological, pulmonary or cardiovascular disorders.

• Known allergy to L-carnosine

• Unwillingness or inability to follow or comply with the procedures outlined in the protocol.