Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition (NARKOREX)

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. Identifier: NCT00484757
Recruitment Status : Unknown
Verified April 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2007
Last Update Posted : April 3, 2009
Information provided by:
Zentrum für Integrative Psychiatrie

Brief Summary:
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: Orexine A Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Basic Science
Study Start Date : June 2007
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Effect of orexine A on sleep, neurocognition and immune-system

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Narcolepsy
  • Age >18
  • Informed consent
  • GERMAN fluently spoken

Exclusion Criteria:

  • Additional severe psychiatric or somatic disorders
  • Pregnancy or nursing
  • Anemia (Hb<10g/dl)

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 identifier (NCT number): NCT00484757

Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie Identifier: NCT00484757     History of Changes
Other Study ID Numbers: Narkorex
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

Keywords provided by Zentrum für Integrative Psychiatrie:

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders