SchizophreniaPhase 2/3CACTISNCT02686697
Carnosine and Cognitive Training in Schizophrenia
A Phase 2/3 study testing L-Carnosine and Cognitive Training in people with Schizophrenia, run by Abraham Reichenberg at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- L-Carnosine and Cognitive Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 19 Jul 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Double-blind, Placebo-controlled Study on the Effects of Combined L-Carnosine and Cognitive Training on Cognition in Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- L-Carnosine, Placebo, Cognitive Training
- Keywords
- L-Carnosine, Schizophrenia, Psychosis, Cognition
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnosineDrug
Also called Carnosine
PlaceboDrug
Cognitive TrainingBehavioural
Cognitive Training for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: L-Carnosine; Behavioral: Cognitive Training |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
The Learning Rate
The Learning Rate will test whether the group receiving L-carnosine increased performance is due to a greater learning rate.
Measured: 8 weeks
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.
Measured: 8 weeks and 10 weeks
Matrix Consensus Cognitive Battery (MCCB)
MCCB composite score will test whether the enhanced learning on specific tasks will generalize into enhanced performance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start1 Dec 2015
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abraham Reichenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor-investigator, Abraham Reichenberg, Icahn School of Medicine at Mount Sinai
- Investigators
- Avi Reichenberg, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686697
- Sponsor's protocol ID
- GCO 14-1119
- Acronym
- CACTIS
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2016
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study on the Effects of Combined L-Carnosine and Cognitive Training on Cognition in Schizophrenia
- ClinicalTrials.gov ID
- NCT02686697
- Acronym / sponsor ID
- CACTIS / GCO 14-1119
- Conditions
- Schizophrenia
- Keywords
- L-Carnosine, Schizophrenia, Psychosis, Cognition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abraham ReichenbergUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Carnosine | Experimental | Drug: L-Carnosine, Behavioral: Cognitive Trainingoral doses of 2000mg for 4 weeks total - 2 weeks medication phase only, and then 2 weeks combined treatment with cognitive training. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Cognitive Trainingmatching placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnosineAlso: Carnosine | Drug | L-Carnosine |
| Placebo | Drug | Placebo |
| Cognitive TrainingCognitive Training for 2 weeks | Behavioural | L-Carnosine, Placebo |
Primary outcome
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.
3 secondary outcomes
The Learning Rate
Time frame: 8 weeks
Change in Performance Advantage
Time frame: 8 weeks and 10 weeks
Matrix Consensus Cognitive Battery (MCCB)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Reichenberg, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L-Carnosine and Cognitive Training in people with Schizophrenia, run by Abraham Reichenberg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Training Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.