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A Screening Study To Assess The Cognition Status in Healthy Volunteers

Completed
Conditions
Healthy Volunteer
Registration Number
NCT01926873
Lead Sponsor
Hoffmann-La Roche
Brief Summary

This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
240
Inclusion Criteria
  • Healthy volunteers, 18 to 65 years of age, inclusive
  • Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
  • A body mass index between 18 to 30 kg/m2 inclusive
  • Able to participate and willing to give written informed consent and to comply with the study restrictions
  • At least second generation resident in the country of origin
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Exclusion Criteria
  • Current or past history of a psychiatric disorder
  • Family history of psychiatric disorders
  • Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
  • Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
  • Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
  • Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
  • Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
  • Resting Pulse Rate greater than 100 or less than 45 beats per minute
  • Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
  • Participation in an investigational drug study within 1 month prior to baseline
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cognitive status of volunteers6 weeks
Secondary Outcome Measures
NameTimeMethod
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