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

NCT02088983 | Unknown Phase 2

• 1 other identifier: 2013031
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

First Episode Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

• Acute Effects of CDP-Choline on Cognition

  1 year

Other Outcomes (1)

• Exploratory Objective: Genetic Differences

  1 year

Study Arms (2)

CDP-Choline

EXPERIMENTAL

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

Dietary Supplement: CDP-Choline

Placebo (cellulose)

PLACEBO COMPARATOR

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

Dietary Supplement: Cellulose

Interventions

CDP-Choline DIETARY_SUPPLEMENT

Capsule

Also known as: citicoline

CDP-Choline

Cellulose DIETARY_SUPPLEMENT

Capsule

Placebo (cellulose)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• The Ottawa Hospital: collaborator

Study Sites (1)

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

Location

MeSH Terms

Interventions

Cytidine Diphosphate Choline; Cellulose

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Verner Knott, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verner Knott, Ph.D.

CONTACT

613-722-6521; verner.knott@theroyal.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 17, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)