Influence of Salbutamol on Emotional and Cognitive Functi... | NCT01957293

Studies
Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

NCT01957293

Sponsor

Prof. Dominique de Quervain, MD

Status

Completed

Last Update Posted

Dec 16, 2014Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Memory Functions

Interventions

Salbutamol
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Sep 24, 2013

First Submission Date that Met QC Criteria

Sep 30, 2013

First Posted Date

Oct 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dominique de Quervain, MD, Director of teh Division of Cognitive Neuroscience, University of BaselSponsor-Investigator

Lead Sponsor

Prof. Dominique de Quervain, MDOTHER

Collaborators

Name	Class
Clinical Trial Unit, University Hospital Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Salbutamol	Experimental		Drug: Salbutamol
Sugar Syrup	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salbutamol	Drug	single oral administration, 4 mg	Salbutamol
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of emotional memory functions under Salbutamol	memory tests	two testing days within 10 days
Change of episodic memory functions under Salbutamol	memory tests	two testing days within10 days

Secondary Outcomes

Measure	Description	Time Frame
Change of emotional state under salbutamol	questionnaires	Two testing days within 10 days
change of attention functions under salbutamol	attention tests

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis -

Exclusion Criteria:

Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique de Quervain, Prof. MD	University of Basel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel, Division of Cognitive neuroscience		Basel		4055	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D000420	Albuterol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided