Carnosine and Cognitive Training in Schizophrenia

NCT02686697 | Completed Phase 2

• 1 other identifier: GCO 14-1119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

L-Carnosine; Schizophrenia; Psychosis; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Learning Rate

  8 weeks

• Change in Performance Advantage

  8 weeks and 10 weeks

• Matrix Consensus Cognitive Battery (MCCB)

  8 weeks

Study Arms (2)

L-Carnosine

EXPERIMENTAL

oral doses of 2000mg for 4 weeks total - 2 weeks medication phase only, and then 2 weeks combined treatment with cognitive training.

Drug: L-Carnosine; Behavioral: Cognitive Training

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo; Behavioral: Cognitive Training

Interventions

L-Carnosine DRUG

Also known as: Carnosine

L-Carnosine

Placebo DRUG

Placebo

Cognitive Training BEHAVIORAL

Cognitive Training for 2 weeks

L-Carnosine; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abraham Reichenberg: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Carnosine; Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Avi Reichenberg, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2015
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

US (1)