Clinical trial NCT02088983: Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia
Official title: Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: First Episode Schizophrenia
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2014-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Effects of CDP-Choline
timeFrame: 1 year
Secondary outcomes:
measure: Acute Effects of CDP-Choline on Cognition
timeFrame: 1 year
Other outcomes:
measure: Exploratory Objective: Genetic Differences
timeFrame: 1 year
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Verner Knott, PhD
role: PRINCIPAL_INVESTIGATOR
References: