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The effects of vardenafil on cognition in healthy subjects; an EEG study

The effects of vardenafil on cognition in healthy subjects; an EEG study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25199
Enrollment
18
Registered
2008-03-28
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

cognition, EEG, vardenafil cognitie, EEG, vardenafil

Interventions

The study will be conducted according to a double-blind, placebo-controlled, 3-way cross-over design. Order of treatments (vardenafil 10 mg, vardenafil 20 mg and a placebo) will be balanced over three

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Volunteers who are male or female, 2. 18 to 35 years of age, 3. Healthy (i.e. absence of all exclusion criteria), 4. Normal static binocular acuity (corrected or uncorrected), 5. Body mass index between 18.5 and 30, 6. Willingness to sign an informed consent, 7. Positive evaluation on the screening.

Exclusion criteria

Exclusion criteria: 1. Excluded will be those volunteers who suffer from or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness. 2. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), 3. Pregnancy or lactation, 4. Use of medication other than oral contraceptives, 5. Use of recreational drugs from 2 weeks before until the end of the experiment, 6. Any sensory or motor deficits which could reasonably be expected to affect test performance. 7. 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 outcome is the behavioural score on the memory tests; the verbal learning task (VLT), the spatial memory task (SMT) and the continuous recognition memory task (CRMT). Secondary, the event-related potentials during those tasks will be analyzed.

Secondary

MeasureTime frame
Other important outcomes are the behavioural scores on the Tower of London (TOL) and the Stroop task. In addition, 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.

Contacts

Public ContactOlga Reneerkens

Department of Neuroscience Maastricht University PO Box 616

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)