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 : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: L-Carnosine Drug: Placebo Behavioral: Cognitive Training||Phase 2 Phase 3|
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has shown some improvements in cognitive outcomes in autism (Chez et al, 2002) and schizophrenia (Chengappa et al; unpublished).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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||December 2018|
|Estimated Study Completion Date :||December 2018|
oral doses of 2000mg for 4 weeks total - 2 weeks medication phase only, and then 2 weeks combined treatment with cognitive training.
Other Name: CarnosineBehavioral: Cognitive Training
Cognitive Training for 2 weeks
Placebo Comparator: Placebo
Behavioral: Cognitive Training
Cognitive Training for 2 weeks
- 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.
- 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.
- 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.
- 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
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
|Contact: Caitlin O'Neill, MPHemail@example.com|
|Contact: Tom Pavlichfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Avi Reichenberg, PhD|
|Principal Investigator:||Avi Reichenberg, PhD||Icahn School of Medicine at Mount Sinai|