Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia
|ClinicalTrials.gov Identifier: NCT02088983|
Recruitment Status : Unknown
Verified March 2014 by Dr. Verner Knott, University of Ottawa.
Recruitment status was: Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|First Episode Schizophrenia||Dietary Supplement: CDP-Choline Dietary Supplement: Cellulose||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2016|
Single dose of 500 mg, 1000 mg, or 2000 mg given in one of 4 test sessions
Dietary Supplement: CDP-Choline
Other Name: citicoline
Placebo Comparator: Placebo (cellulose)
Given randomly in one of the 4 testing sessions as a comparison
Dietary Supplement: Cellulose
- Acute Effects of CDP-Choline [ Time Frame: 1 year ]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).
- Acute Effects of CDP-Choline on Cognition [ Time Frame: 1 year ]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.
- Exploratory Objective: Genetic Differences [ Time Frame: 1 year ]Although the sample size is relatively small, this study will begin to explore differences in CDP-choline response by classifying patients by CHRNA7 levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088983
|Contact: Verner Knott, Ph.D.||613-722-6521 ext email@example.com|
|University of Ottawa Institute of Mental Health Research|
|Ottawa, Ontario, Canada, K1Z 7K4|
|Contact: Verner Knott, PhD 613-722-6521 ext 6843 firstname.lastname@example.org|
|Principal Investigator:||Verner Knott, PhD||University of Ottawa|