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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Zentrum für Integrative Psychiatrie.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT00484757
First received: June 8, 2007
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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 Intervention
Narcolepsy
Drug: Orexine A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Zentrum für Integrative Psychiatrie:

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

Study Start Date: June 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484757

Locations
Germany
Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
Investigators
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00484757     History of Changes
Other Study ID Numbers: Narkorex, DFG-SFB654/C5-Narkorex
Study First Received: June 8, 2007
Last Updated: April 2, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Zentrum für Integrative Psychiatrie:
Narcolepsy
Orexines
sleep
cognition
cytokines

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

ClinicalTrials.gov processed this record on October 30, 2014