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

First Episode Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02088983
• Other study ID #: 2013031
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 12, 2014
• Last updated: March 14, 2014
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2014
• Source: University of Ottawa
• Contact: Verner Knott, Ph.D.
• Phone: 613-722-6521
• Email: verner.knott[@]theroyal.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cognition Disorders
• First Episode Schizophrenia
• Schizophrenia

Intervention

Dietary Supplement:
• CDP-Choline
Capsule
• Cellulose
Capsule

Locations

Country	Name	City	State
Canada	University of Ottawa Institute of Mental Health Research	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Ottawa	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Objective: Genetic Differences	Although the sample size is relatively small, this study will begin to explore differences in CDP-choline response by classifying patients by CHRNA7 levels.	1 year	No
Primary	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	No
Secondary	Acute Effects of CDP-Choline on Cognition	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.	1 year	No