LoDi-Basel: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects

• Sponsor: Prof. Dominique de Quervain, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01321021
• Collaborator: Clinical Trial Unit, University Hospital Basel, Switzerland (Other)
• Enrollment: 80
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

This project aims at identifying novel pharmacological targets for the treatment of memory disorders.

Condition or Disease	Intervention/Treatment	Phase
Memory, Long-Term; Memory, Short-Term	Drug: Losartan, Diphenhydramine, Placebo	N/A

Detailed Description

To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Losartan, Diphenhydramine, Placebo placebo controlled crossover study with two arms: Losartan, Diphenhydramine	Drug: Losartan, Diphenhydramine, Placebo; placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg

Outcome Measures

Primary Outcome Measures

1. Primary Outcome Measures [during cognitive testing at study days]

   Memory functions

Secondary Outcome Measures

1. Secondary Outcome Measures [during cognitive testing at study days]

   sleepiness, mood, anxiety, attention, fluid intelligence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy

• native or fluent German-speaking

• BMI between 19 and 27 kg/m2

• 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

• female: willing to perform a pregnancy test at the beginning of both test visits

Exclusion Criteria:

• acute or chronic psychiatric or somatic disorder

• pathological ECG

• known hypersensitivity to the IMP under investigation (losartan, diphenhydramine)

• hypotension (RR < 110/70 mmHg)

• bradycardia (< 50 bpm)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Basel, Division of Cognitive Neuroscience	Basel		Switzerland	4055

Sponsors and Collaborators

• Prof. Dominique de Quervain, MD
• Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

• Principal Investigator: Dominique de Quervain, Prof. MD, University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dominique de Quervain, MD, Prof., MD, University of Basel
• ClinicalTrials.gov Identifier: NCT01321021
• Other Study ID Numbers: 2011DR2032
• First Posted: Mar 23, 2011
• Last Update Posted: May 3, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Diphenhydramine; Promethazine; Losartan

Study Results

No Results Posted as of May 3, 2012