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

University of Ottawa

Status and phase

Unknown

Phase 2

Conditions

First Episode Schizophrenia

Treatments

Dietary Supplement: CDP-Choline

Dietary Supplement: Cellulose

Study type

Interventional

Funder types

Other

Identifiers

NCT02088983

2013031

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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