A Screening Study To Assess The Cognition Status in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926873
• Other study ID #: BP28865
• Secondary ID: 2013-001261-16
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: November 1, 2016
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive status of volunteers		6 weeks	No