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Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02088983
Recruitment Status : Unknown
Verified March 2014 by Dr. Verner Knott, University of Ottawa.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
The Ottawa Hospital
Information provided by (Responsible Party):
Dr. Verner Knott, University of Ottawa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
First Episode Schizophrenia Dietary Supplement: CDP-Choline Dietary Supplement: Cellulose Phase 2

Detailed Description:
  • A sample of 40 patients will be recruited from the Champlain First Episode Psychosis Program, a service of The Ottawa Hospital, which is run in conjunction with the Schizophrenia Program of the Royal Ottawa Mental Health Center.
  • In this randomized, double-blind, placebo-controlled, cross-over design study, participants will attend the laboratory for four test sessions and will receive either a single dose of CDP-choline (500 mg, 1000 mg or 2000 mg) or placebo at each test session
  • EEG recordings (with a focus on the P50 ERP) and cognitive testing measures will be collected in each test session to determine any possible gating or cognitive effects of CDP-choline. A saliva sample will also be collected to determine any genetic differences in the effects of CDP-choline
  • The investigators carefully engineered study aims to assess the optimal dosing of a nicotinic cholinergic agonist, CDP-choline to increase P50 suppression and cognitive efficacy in an early schizophrenia population with abnormal P50 suppression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia
Study Start Date : April 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: CDP-Choline
Single dose of 500 mg, 1000 mg, or 2000 mg given in one of 4 test sessions
Dietary Supplement: CDP-Choline
Other Name: citicoline

Placebo Comparator: Placebo (cellulose)
Given randomly in one of the 4 testing sessions as a comparison
Dietary Supplement: Cellulose

Primary Outcome Measures :
  1. Acute Effects of CDP-Choline [ Time Frame: 1 year ]
    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).

Secondary Outcome Measures :
  1. Acute Effects of CDP-Choline on Cognition [ Time Frame: 1 year ]
    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.

Other Outcome Measures:
  1. Exploratory Objective: Genetic Differences [ Time Frame: 1 year ]
    Although the sample size is relatively small, this study will begin to explore differences in CDP-choline response by classifying patients by CHRNA7 levels.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female
  • 18 - 60 years old
  • Meet DSM-IV/DSM-IV-TR criteria for First Episode Schizophrenia
  • Clinical stability of the past 2 months [assessed with the PANSS]
  • Treatment with a single antipsychotic medication (concomitant psychiatric medications allowing on an "if needed basis".
  • Smoker or non-smoker

Exclusion Criteria:

  • Any comorbid Axis I disorder including a current or recent history of alcohol/substance abuse
  • A clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment
  • Recent head trauma (<6mos)
  • Major learning disability
  • Body mass index >38kg/m¬2
  • Use of illicit drugs
  • Abnormal hearing

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 identifier (NCT number): NCT02088983

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Contact: Verner Knott, Ph.D. 613-722-6521 ext 6843

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Canada, Ontario
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Verner Knott, PhD    613-722-6521 ext 6843   
Sponsors and Collaborators
University of Ottawa
The Ottawa Hospital
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Principal Investigator: Verner Knott, PhD University of Ottawa
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Responsible Party: Dr. Verner Knott, Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory, University of Ottawa Identifier: NCT02088983    
Other Study ID Numbers: 2013031
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders
Cytidine Diphosphate Choline
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents