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Effects of vardenafil on cognition in healthy adults: an EEG study

Effects of vardenafil on cognition in healthy adults: an EEG study - Vardenafil and cognition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32222
Enrollment
40
Registered
2008-04-24
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen aandoening nvt

Interventions

Participants will be treated with vardenafil 10 mg, vardenafil 20 mg, or a placebo. All treatments will be taken orally. The treatment order will be established by counterbalancing.

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or female, 18 to 35 years of age, Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected), Body mass index between 18.5 and 30, Willingness to sign an informed consent, Positive evaluation on the screening

Exclusion criteria

Exclusion criteria: A history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, and any sensory or motor deficits which could reasonably be expected to affect test performance. Those volunteers who have a first-degree relative with a psychiatric disorder or a history of a psychiatric disorder will also be excluded.

Design outcomes

Primary

MeasureTime frame
The main endpoint is the behavioural score on the memory tests; the verbal learning task (VLT), the object relocation task (ORT) and the continuous recognition memory task (CRMT),. Secondary, the event-related potentials during those tasks will be analysed.

Secondary

MeasureTime frame
Other important measures are the Tower of London (TOL) and the Stroop task. In addition, the visual and auditory evoked potentials (respectively VEPs and AEPs), which will give an indication of the role of vardenafil in information processing are important measures as well. Finally, the ratio (S2/S1) of the P50 is a measure of sensory gating.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)