Research with human participants

Overview of medical research in the Netherlands

A Phase I, open label trial in healthy subjects to evaluate the central nervous receptor occupancy of pipamperone at the 5-HT2A and D2 receptor by means of Positron Emission Tomography.

Published:
Last updated:

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Mood disorders and disturbances NEC
Study type
Interventional

ID

NL-OMON34843

Source

ToetsingOnline

Brief title

Pipamperone PET study

Condition

  • Mood disorders and disturbances NEC

Synonym

depression, major depressive disorder

Research involving

Human

Sponsors and support

Primary sponsor :
PharmaNeuroBoost NV
Source(s) of monetary or material Support :
PharmaNeuroBoost

Intervention

Keyword :
PET, Pipamperone, receptor occupancy

Outcome measures

Primary outcome

-

Secondary outcome

-

Background summary

-

Study objective

-

Study design

-

Intervention

-

Study burden and risks

-

Public
PharmaNeuroBoost NV

Alkerstraat 30 A
3570 Alken
Belgium
Scientific
PharmaNeuroBoost NV

Alkerstraat 30 A
3570 Alken
Belgium

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Healthy males and females
Between 35 and 75 years of age

Exclusion criteria

Clinical significant abnormalities for medical examination

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Dipiperon
Generic name :
Pipamperone
Registration
:
Yes - NL outside intended use
Product type :
Medicine
Brand name :
not applicable
Generic name :
pipamperone

Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2009-012699-28-NL
CCMO NL30815.056.09