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Completed

NCT Number: NCT01926873

A Screening Study To Assess The Cognition Status in Healthy Volunteers

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Freiburg im Breisgau, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Cognitive status of volunteers

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

MULTI-CENTER COGNITION ASSESSMENT IN HEALTHY SUBJECTS TO COLLECT REFERENCE DATA FOR COMPARISON TO PATIENTS WITH DEPRESSION

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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