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The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00660751
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.

Condition or disease Intervention/treatment
Healthy Drug: Duloxetine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control
Actual Study Start Date : August 2007
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Drug: Duloxetine
SNRIs
Placebo Comparator: 2 Drug: Duloxetine
SNRIs


Outcome Measures

Primary Outcome Measures :
  1. level of DNIC [ Time Frame: 1 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • age 18-80
  • no chronic disease

Exclusion Criteria:

  • Subjects who suffer from chronic pain / pain syndrome
  • use of anti-depressant or anti-psychotic drugs
  • food/ drugs sensitivity
  • breast feeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660751


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Prof. David Yarnitsky
More Information

Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00660751     History of Changes
Other Study ID Numbers: DNIC01CTIL
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by d_yarnitsky, Rambam Health Care Campus:
Physiology of Serotonergic and Adrenergic systems

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Adrenergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents