The Impact of Caffeine on Cognition in Schizophrenia

NCT02832401 | Completed

• 1 other identifier: 1021504
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Caffeine

Keywords

event-related potentials; EEG; caffeine; psychosis; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Event-related potentials (ERPs)

  Average neuroelectric brain response measured in microvolts. Event-related potentials include N2pc (visual search) and P300 (visual search, AX-CPT and N-Back)

  30 minutes post-intervention during both test sessions

Secondary Outcomes (6)

• Response accuracy

  30 minutes post-intervention during both test sessions

• Reaction Time

  30 minutes post-intervention during both test sessions

• False alarms

  30 minutes post-intervention during both test sessions

• d'

  30 minutes post-intervention during both test sessions

• C

  30 minutes post-intervention during both test sessions

Study Arms (2)

Caffeine

ACTIVE COMPARATOR

200 mg of caffeine powder administered in capsules

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Cellulose powder administered in capsules

Drug: Placebo

Interventions

Caffeine DRUG

Caffeine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator
• Mount Saint Vincent University: collaborator

Study Sites (1)

BIOTIC Neuroimaging Laboratory

Halifax, Nova Scotia, Canada

Location

Related Publications (53)

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Derek Fisher, Ph.D.

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 14, 2016
• Study Start: September 2, 2016
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2019
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)