Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Cephalon
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00670813
First received: April 30, 2008
Last updated: July 19, 2011
Last verified: April 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Improvement on the Hamilton Depression Scale (6-Item Version) from Baseline to Follow-up [ Time Frame: Baseline, 24 h (after sleep deprivation night), 48 h (after the first recovery night) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responders (50% reduction on the HAMD-6) in the modafinil group versus the placebo group [ Time Frame: Baseline, 24 h (after sleep deprivation night), 48 h (after the first recovery night) ] [ Designated as safety issue: No ]
  • self-rating scale of global mental state (Befindlichkeitsskala (Bf-s)) and the Stanford Sleepiness Scale. [ Time Frame: Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night) ] [ Designated as safety issue: No ]
  • Polysomnography (among others assessing sleep onset latency, sleep efficiency, sleep states, wakefulness after sleep onset) [ Time Frame: Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night) ] [ Designated as safety issue: No ]
  • Neuropsychological battery (including Zahlenverbindungstest, California Verbal Learning Test, d2 Attention Stress Test, Farb-Wort-Interferenztest, CS fine motor task [ Time Frame: Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night) ] [ Designated as safety issue: No ]

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
Experimental: Modafinil (Vigil)
"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
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
Placebo Comparator: Placebo
"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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatients of the Psychiatric Hospital of the Technical University of Munich
  • Diagnoses: Depressive episode with somatic symptoms (ICD-10: F32.01, F32.11, F32.21) or Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21) or Bipolar affective disorder, presently depressive episode with somatic syndrome (F31.31, F31.41)
  • Age 18 - 70 years
  • Hamilton Depression Score (HAMD-21) at baseline > 18
  • Women at child-bearing age have to provide a negative pregnancy test before study inclusion and have to use an effective, reliable and safe method of contraception throughout the study
  • The patient must be able to understand the explanations about the study and to understand and follow the instructions of the investigator
  • The patient is not involuntarily hospitalized under German law (§ 63 Strafgesetzbuch)

Exclusion Criteria:

  • Presence of psychotic symptoms ICD-10: F32.3, F33.3, F31.5)
  • Present psychiatric comorbidity (e.g. substance dependence)
  • Relevant medical conditions
  • Acute suicidality
  • History of seizures
  • Paroxysmal EEG activity
  • Contraindications against treatment with modafinil (please see the most recent product information from August 2006:
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670813

Locations
Germany
Centre for Sleep Disorders of the Department of Psychiatry and Psychotherapy
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Cephalon
Investigators
Principal Investigator: Michael H Wiegand, Prof. Dr.med. Dipl. Psych. Head of the Centre for Sleep Disorders
  More Information

Publications:
Wiegand MH. Schlaf, Schlafentzug und Depression. Experimentelle Studien zum therapeutischen Schlafentzug. Berlin Heidelberg New York: Springer, 1995
Wiegand MH, Jahn T, Schröder MM, Pohl C, Veselý B, Veselý Z, Brückner T, Bäuml J. Spontaneous sleep and microsleep episodes and mood in depressed patients during 40 hours of sleep deprivation therapy. Eur Arch Psychiat Clin Neurosci 256 Suppl. 2, II751, 2006

Responsible Party: Michael H. Wiegand, Professor Dr.med. Dr.med.habil. Dipl.-Psych., Sleep Laboratory Department of Psychiatry and Psychotherapy of the Technical University Munich
ClinicalTrials.gov Identifier: NCT00670813     History of Changes
Other Study ID Numbers: SE03, EudraCT Nr. 2005-003196-21
Study First Received: April 30, 2008
Last Updated: July 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Depression
(total) sleep deprivation
Modafinil
polysomnography sleep

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Deprivation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014