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

NCT ID: NCT02088983

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

First Episode Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

CDP-Choline

Single dose of 500 mg, 1000 mg, or 2000 mg given in one of 4 test sessions

Group Type: EXPERIMENTAL

CDP-Choline

Intervention Type: DIETARY_SUPPLEMENT

Capsule

Placebo (cellulose)

Given randomly in one of the 4 testing sessions as a comparison

Group Type: PLACEBO_COMPARATOR

Cellulose

Intervention Type: DIETARY_SUPPLEMENT

Capsule

Interventions

CDP-Choline

Capsule

Intervention Type: DIETARY_SUPPLEMENT

Cellulose

Capsule

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

citicoline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Dr. Verner Knott

Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Verner Knott, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Locations

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Verner Knott, Ph.D.

Role: CONTACT

verner.knott@theroyal.ca

613-722-6521 ext. 6843

Facility Contacts

Verner Knott, PhD

Role: primary

verner.knott@theroyal.ca

613-722-6521 ext. 6843

Other Identifiers

2013031

Identifier Type: -

Identifier Source: org_study_id