A Screening Study To Assess The Cognition Status in Healthy Volunteers

Completed

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01926873

Run by

Hoffmann-La Roche

People needed

240

Starts

2013-08-01

Expected to finish

2014-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — San Diego, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Oak Brook, Illinois, United States
• Study site — Cedarhurst, New York, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Freiburg im Breisgau, Germany
• Study site — Mainz, Germany
• Study site — Mannheim, Germany
• Study site — Schwerin, Mecklenburg-Vorpommern, Germany
• Study site — Bialystok, Poland
• Study site — Choroszcz, Poland
• Study site — Tuszyn, Poland

Full record on ClinicalTrials.gov

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