Schizophrenia Clinical Trial
— CACTISOfficial title:
A Double-blind, Placebo-controlled Study on the Effects of Combined L-Carnosine and Cognitive Training on Cognition in Schizophrenia
Verified date | August 2022 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 19, 2022 |
Est. primary completion date | July 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Abraham Reichenberg | Stanley Medical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive Training Score | Cognitive Training Score will test whether the combination of L-carnosine with cognitive training will significantly increase the performance of patients with schizophrenia on memory and learning training tasks compared to pairing cognitive training with placebo. | 8 weeks | |
Secondary | The Learning Rate | The Learning Rate will test whether the group receiving L-carnosine increased performance is due to a greater learning rate. | 8 weeks | |
Secondary | Change in Performance Advantage | Performance Advantage will test whether performance advantage is retained after cessation of L-carnosine and training, contrary to a state-dependent effect. Compares performance between week 10 and week 8. An advantage (if exists) is a difference between the treatment arm and the placebo arm of the trial on the primary outcome measure. For an advantage the treatment arm should perform better than the placebo arm. If there is no difference between the groups or that the placebo group performs better than the treatment group than the treatment offers no advantage. | 8 weeks and 10 weeks | |
Secondary | Matrix Consensus Cognitive Battery (MCCB) | MCCB composite score will test whether the enhanced learning on specific tasks will generalize into enhanced performance | 8 weeks |
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