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Sponsors and Collaborators: |
Technische Universität München Cephalon GmbH |
Information provided by: | Technische Universität München |
ClinicalTrials.gov Identifier: | NCT00670813 |
The study aims to investigate whether the administration of the stimulant modafinil during a 40 hour sleep deprivation period in depressed patients can intensify the antidepressant effect of the sleep deprivation as assessed by a reduction in the Hamilton Depression score (HAMD, 6-item version). We postulate that this also correlates with a reduction of the polysomnographically assessed overall amount of sleep during this period.
Condition | Intervention | Phase |
Depression |
Drug: Modafinil (Vigil) Drug: Placebo |
Phase II |
MedlinePlus related topics: | Depression |
ChemIDplus related topics: | Modafinil Gelatin |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Verstärkung Der Therapeutischen Wirkung Von Schlafentzug Durch Modafinil - Eine Doppelblinde, Randomisierte, Placebokontrollierte Monozentrische Studie Der Phase II (Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil - a Double Blind, Placebo-Controlled Monocentric Phase II Study) |
Estimated Enrollment: | 30 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Modafinil (Vigil): Experimental
"Modafinil" Arm: during the 40 h sleep deprivation period (morning until evening next day) the depressed patient receives 200 mg of Modafinil each at 12:00, 24:00 and again at 12:00 o' clock
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Drug: Modafinil (Vigil)
Oral application of 2 x 100 mg Modafinil each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period
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Placebo: Placebo Comparator
"Placebo" Arm: during the 40 h sleep deprivation period (morning until evening next day) the depressed patient receives Placebo at 12:00, 24:00 and again at 12:00 o' clock
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Drug: Placebo
Oral application of 2 x 100 mg Placebo each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Inge Schlenker | 49-089-4140 ext 4231 | Inge.Schlencker@lrz.tu-muenchen.de |
Germany | |||||
Centre for Sleep Disorders of the Department of Psychiatry and Psychotherapy | Not yet recruiting | ||||
Munich, Germany, 81675 | |||||
Contact: Michael H. Wiegand, Prof. Dr.med. Dipl. Psych. 49-089-4140 ext 4248 michael.wiegand@lrz.tum.de | |||||
Contact: Helen C. Slawik, MD | |||||
Principal Investigator: Michael H. Wiegand, Prof. Dr.med. Dipl.-Psych. | |||||
Sub-Investigator: Helen C. Slawik, MD | |||||
Sub-Investigator: Gwendolyn Böhm, MD |
Technische Universität München |
Cephalon GmbH |
Principal Investigator: | Michael H Wiegand, Prof. Dr.med. Dipl. Psych. | Head of the Centre for Sleep Disorders |
Responsible Party: | Sleep Laboratory Department of Psychiatry and Psychotherapy of the Technical University Munich ( Michael H. Wiegand, Professor Dr.med. Dr.med.habil. Dipl.-Psych. ) |
Study ID Numbers: | SE03, EudraCT Nr. 2005-003196-21 |
First Received: | April 30, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00670813 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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