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Carnosine and Cognitive Training in Schizophrenia (CACTIS)

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ClinicalTrials.gov Identifier: NCT02686697
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Avraham Reichenberg, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: L-Carnosine Drug: Placebo Behavioral: Cognitive Training Phase 2 Phase 3

Detailed Description:

Compromised cognitive functioning is a core feature of schizophrenia, yet it remains a major unmet need in the treatment of schizophrenia. Current available therapeutic approaches to enhance cognition in schizophrenia - either pharmacological or non-pharmacological (for a review) have yielded, at best, only modest results with questionable retention of the cognitive benefits and generalization of the effects into functional benefit. The investigators propose a novel approach to enhance cognition in schizophrenia: combining a food supplement with cognitive training, rather than using each intervention alone.

Aim is to test the primary hypothesis that 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. The investigators will also test the secondary hypotheses that in the group receiving L-carnosine increased performance is due to a greater learning rate. Carnosine has antioxidant and antiglycating action and is found in food and the human body. The investigator's choice is guided by several considerations but, primarily the evidence that L-carnosine has neuroprotective effects through its antioxidant features. Briefly, the investigators propose that alterations in metabolism in several neurotransmitter systems (particularly glutamate) can both contribute to, and be modified by, oxidative stress, and therefore antioxidant administration could positively affect neurotransmitter role in synaptic plasticity, learning and memory.

Carnosine has shown some improvements in cognitive outcomes in autism (Chez et al, 2002) and schizophrenia (Chengappa et al; unpublished). Chez used oral doses of 800mg/d for 8 weeks; while the latter study used oral doses of 2000mg for 4 weeks showing positive effects. Hence this is the dose and delivery route that will be used. The investigators have opted for 4 weeks course following broadly from these two studies. Carnosine is widely available from health and food supplement shops in the UK and US retail market in highly pure form; is a naturally occurring in food and the human body; and is well-tolerated and has a benign side-effect profile, as shown from previous trials, and is therefore not associated with any potential risks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study on the Effects of Combined L-Carnosine and Cognitive Training on Cognition in Schizophrenia
Study Start Date : December 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: L-Carnosine
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
Other Name: Carnosine

Behavioral: Cognitive Training
Cognitive Training for 2 weeks

Placebo Comparator: Placebo
matching placebo
Drug: Placebo
Behavioral: Cognitive Training
Cognitive Training for 2 weeks




Primary Outcome Measures :
  1. Cognitive Training Score [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. The Learning Rate [ Time Frame: 8 weeks ]
    The Learning Rate will test whether the group receiving L-carnosine increased performance is due to a greater learning rate.

  2. Change in Performance Advantage [ Time Frame: 8 weeks and 10 weeks ]
    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.

  3. Matrix Consensus Cognitive Battery (MCCB) [ Time Frame: 8 weeks ]
    MCCB composite score will test whether the enhanced learning on specific tasks will generalize into enhanced performance



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686697


Contacts
Contact: Laurent Smith, BA 646-937-3239 lauren.smith1@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Avi Reichenberg, PhD         
Sponsors and Collaborators
Avraham Reichenberg
Stanley Medical Research Institute
Investigators
Principal Investigator: Avi Reichenberg, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Avraham Reichenberg, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02686697     History of Changes
Other Study ID Numbers: GCO 14-1119
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by Avraham Reichenberg, Icahn School of Medicine at Mount Sinai:
L-Carnosine
Schizophrenia
Psychosis
Cognition

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders