A Phase 2 interventional study of CDP-Choline and Cellulose in First Episode Schizophrenia, sponsored by University of Ottawa. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-03-17.
Sponsored by University of Ottawa · Phase 2 and Interventional
People with schizophrenia tend to have problems with attention and concentration. Studies found that these patients are unable to block or gate out non-relevant and distracting information (e.g., noises). This may lead to brain overload. Cognitive abilities like concentration, memory, and learning may worsen. This ability to filter sensory information has been linked to a gene that affects the way nicotine acts in the brain. Patients with schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of the general population. It has been suggested that these patients may use nicotine to improve their ability to block out distracting information. Brain wave activity (EEG) in response to sounds has been proved useful in understanding this gating problem. The present study uses EEG measures and performance tasks to find out what a new nicotine-like treatment, which will be added to ongoing treatment medications, does to gating and cognition. It is hoped that this new treatment will improve the way in which patients process information, as this may help them in day-to-day activities.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Ottawa is the lead sponsor of 123 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Single dose of 500 mg, 1000 mg, or 2000 mg given in one of 4 test sessions
Dietary Supplement: CDP-Choline
Given randomly in one of the 4 testing sessions as a comparison
Dietary Supplement: Cellulose
Capsule
Also known as: citicoline
Capsule
Acute Effects of CDP-Choline
To examine the acute effects of CDP-choline on P50 auditory gating deficits in FES. Complementing this, we will measure CDP-choline response as a function of dose, administering doses at 3 clinically recommended levels (500 mg, 1000 mg, 2000 mg).
Time frame: 1 year
Acute Effects of CDP-Choline on Cognition
Although sensory processing and neurocognitive processing show poor interrelatedness in SZ (vs. healthy controls) and evidence supporting a relationship between sensory gating and specific cognitive domains is mixed, auditory gating consistently predicts variance in tasks of attention, working memory and less so in executive functioning. Its nicotinic improvements in relatively low-level sensory processes might also be expected to translate into benefits for more complex cognitive processes that are required for functional daily living. A secondary objective of this research will assess the acute effects of CDP-choline on cognitive operations. This will be conducted using a test battery assessing seven orthogonal domains of cognition designated by MATRICS as targets for clinical assessment of potential cognitive enhancers for SZ.
Time frame: 1 year
Exploratory Objective: Genetic Differences
Although the sample size is relatively small, this study will begin to explore differences in CDP-choline response by classifying patients by CHRNA7 levels.
Time frame: 1 year
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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University of Ottawa