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Tackling the effect of duloxetine on brain function in mood specific emotional processing in healthy volunteers: An fMRI study bridging pharmacotherapeutical and cognitive psychological approaches to depression

Tackling the effect of duloxetine on brain function in mood specific emotional processing in healthy volunteers: An fMRI study bridging pharmacotherapeutical and cognitive psychological approaches to depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24781
Enrollment
24
Registered
2008-09-25
Start date
2008-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression, mood disorders, depressie, stemmingsstoornis

Interventions

This study will be a double-blind, placebo-controlled, cross-over study. Volunteers will be randomly assigned to one of two treatment sequences. Each volunteer will receive the dual action antidepress

Sponsors

Radboud University Nijmegen Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects must be at least 18 but not older than 50 years of age. 2. Subjects must have given a written informed consent. 3. They must have good physical and mental health as determined by medical history and medical, ECG and laboratory examination. 4. Their Body Mass Index between 18.5-24.9.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to duloxetine or any of the inactive ingredients. 2. Contra-indications for duloxetine (hepatic impairment, severe renal impairment with a GFR 170 mm Hg; diastolic > 100 mm Hg; 13. Participation in another drug study within 3 months preceding this study; 14. Orthostatic dysregulation at the screening examination; 15. Uncontrolled Narrow-Angle Glaucoma; 16. Post-menopausal women, pregnant women, lactating women and women without adequate hormonal anticonception; 17. Inability to understand the nature and extent of the trial and the procedures required; 18. Inability to understand the procedures of the neuropsycholoigcal tests; 19. Contraindication to MRI.

Design outcomes

Primary

MeasureTime frame
Main outcome-measures consist of behavioral measures as well as statistical maps of the functional imaging data as measured by fMRI. Three tests will be administered targetting: - perception of emotionally valenced pictures - the processing of punishment and reward monetary reward task - memory bias with regards to emotional valence.

Secondary

MeasureTime frame
Behavioral measures on: mood, anxiety, and hostility.

Contacts

Public ContactRobbert J Verkes

Radboud University Nijmegen Medical Centre Department of Psychiatry, 966 PO Box 9101

r.verkes@psy.umcn.nl+31 (0)24 3613970

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)