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The Impact of Caffeine on Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02832401
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Dalhousie University
Mount Saint Vincent University
Information provided by (Responsible Party):
Derek Fisher, Nova Scotia Health Authority

Brief Summary:
Caffeine is the most used psychoactive drug in Canada, with regular consumption by 88% of the adult population, While rates of caffeine consumption are considered to be high in the general population, there is some evidence that they may be even higher within schizophrenia patients; in a 2006 U.S. study, daily consumption rates of caffeine were nearly double those observed in a healthy control population (471.6 mg/day vs. 254.2 mg/day). Furthermore, 13% of the schizophrenia population studied ingested more than 1000 mg/day of caffeine, well above the 400 mg daily maximum recommended by Health Canada. High doses of caffeine are particularly concerning for individuals with schizophrenia; caffeine alters dopaminergic activity at post-synaptic neurons through its actions at adenosine A2A receptors, which may exacerbate positive symptoms, such as delusions and hallucination. This significant rate of consumption is likely due in part to caffeine's actions on the human brain, resulting in increased arousal, elevated mood and beneficial effects on a wide-range of cognitive processes including verbal working memory, sustained attention, and executive function. These areas of caffeine-induced cognitive improvement notably overlap with the cognitive domains that are reported to be diminished in schizophrenia. Despite this overlap and the rates of caffeine consumption observed within schizophrenia, research reports examining the effects of caffeine on cognition and brain activity are all but non-existent in this population. The primary objective of this proposal is to compare the effects of caffeine and placebo on brain function during cognitive tasks in participants with schizophrenia. While the investigators have specific hypotheses for each task, overall the investigators hypothesize that caffeine will improve cognitive function (as evidenced by larger ERP amplitudes and/or reduced ERP latencies) compared to placebo in schizophrenia patients, with similar effects (albeit reduced in magnitude) observed in non-patient healthy controls.

Condition or disease Intervention/treatment Phase
Schizophrenia Caffeine Drug: Caffeine Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Caffeine on Cognition in Schizophrenia
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Caffeine
200 mg of caffeine powder administered in capsules
Drug: Caffeine
Placebo Comparator: Placebo
Cellulose powder administered in capsules
Drug: Placebo



Primary Outcome Measures :
  1. Event-related potentials (ERPs) [ Time Frame: 30 minutes post-intervention during both test sessions ]
    Average neuroelectric brain response measured in microvolts. Event-related potentials include N2pc (visual search) and P300 (visual search, AX-CPT and N-Back)


Secondary Outcome Measures :
  1. Response accuracy [ Time Frame: 30 minutes post-intervention during both test sessions ]
    % of correct responses during performance of visual search, AX-CPT and N-Back

  2. Reaction Time [ Time Frame: 30 minutes post-intervention during both test sessions ]
    Average time from target appearance to correct behavioural response (measured in milliseconds) during performance of visual search, AX-CPT and N-Back

  3. False alarms [ Time Frame: 30 minutes post-intervention during both test sessions ]
    Number of responses to non-target stimuli during performance of visual search, AX-CPT and N-Back

  4. d' [ Time Frame: 30 minutes post-intervention during both test sessions ]
    A measure of signal detection sensitivity, obtained by the following formula: d' = zHits = zFalseAlarms, during performance of visual search, AX-CPT and N-Back

  5. C [ Time Frame: 30 minutes post-intervention during both test sessions ]
    A measure of response bias, obtained by the following formula: C = -0.5(zHits + zFA), during performance of visual search, AX-CPT and N-Back

  6. Checklist of Drug Related Symptoms [ Time Frame: 1 hour post-intervention during both sessions ]
    Assesses physical symptoms potentially arising due to drug administration, including nausea and headache



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient participants: Patients will have a primary diagnosis of schizophrenia and will be judged as clinically stable, as indicated by the patient's primary physician and including no changes in symptoms or antipsychotic medications for the last 2 months, and each participant's primary medication (if any) will be limited to one of the atypical anti-psychotics, excluding clozapine due to the noted interactions. Participants will be required to understand spoken and written English and will be right-handed (assessed by the Edinburgh Handedness Inventory [EHI]) to facilitate source localization techniques. Participants will be required to have normal (or corrected) vision.
  • Healthy controls: Self-report of negative psychiatric, medical, neurological and alcohol/drug abuse histories, and current non-use of medications (with the exception of oral contraceptives). Participants will be required to understand spoken and written English and will be right-handed (assessed by the Edinburgh Handedness Inventory [EHI]) to facilitate source localization techniques. Participants will be required to have normal (or corrected) vision.

Exclusion Criteria:

  • Patients: Patient participants will be excluded if they meet any of the following criteria: co-morbid DSM-IV TR Axis I disorder; current treatment with clozapine; total PANSS score >65, reflecting an acute psychotic episode; current history of drug abuse or dependence; history of head injury resulting in loss of consciousness; diagnosis of epilepsy or any other neurologic disorder; electro-convulsive therapy (ECT) treatment within the previous year; significant cardiac illness; or extrapyramidal symptoms (EPS) resulting in movement disorders which could affect ERP recordings. Additionally, as is common in caffeine research, participants will be excluded if they work night shifts or do not report normal (i.e. nocturnal) sleep patterns during screening
  • Healthy Controls: As is common in caffeine research, participants will be excluded if they work night shifts or do not report normal (i.e. nocturnal) sleep patterns during screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832401


Contacts
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Contact: Derek Fisher, Ph.D. 902.457.5503 derek.fisher@msvu.ca

Locations
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Canada, Nova Scotia
BIOTIC Neuroimaging Laboratory Recruiting
Halifax, Nova Scotia, Canada
Contact: Steven Beyea, Ph.D.    902-473-1868    steven.beyea@iwk.nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
Dalhousie University
Mount Saint Vincent University
Investigators
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Principal Investigator: Derek Fisher, Ph.D. Nova Scotia Health Authority

Publications:

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Responsible Party: Derek Fisher, Affiliated Scientist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02832401     History of Changes
Other Study ID Numbers: 1021504
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Derek Fisher, Nova Scotia Health Authority:
event-related potentials
EEG
caffeine
psychosis
schizophrenia

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents