Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil - Full Text View

Sponsor:	Technische Universität München
Collaborator:	Cephalon
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00670813

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 II

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)

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Modafinil

U.S. FDA Resources

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
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	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: 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	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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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

Contacts

Contact: Inge Schlenker

49-089-4140 ext 4231

Inge.Schlencker@lrz.tu-muenchen.de

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:

Giedke H, Schwärzler F. Therapeutic use of sleep deprivation in depression. Sleep Med Rev. 2002 Oct;6(5):361-77. Review.

Gillin JC, Buchsbaum M, Wu J, Clark C, Bunney W Jr. Sleep deprivation as a model experimental antidepressant treatment: findings from functional brain imaging. Depress Anxiety. 2001;14(1):37-49. Review.

Hemmeter U, Bischof R, Hatzinger M, Seifritz E, Holsboer-Trachsler E. Microsleep during partial sleep deprivation in depression. Biol Psychiatry. 1998 Jun 1;43(11):829-39.

Ringel BL, Szuba MP. Potential mechanisms of the sleep therapies for depression. Depress Anxiety. 2001;14(1):29-36. Review.

Wirz-Justice A, Van den Hoofdakker RH. Sleep deprivation in depression: what do we know, where do we go? Biol Psychiatry. 1999 Aug 15;46(4):445-53. Review.

Wiegand M, Riemann D, Schreiber W, Lauer CJ, Berger M. Effect of morning and afternoon naps on mood after total sleep deprivation in patients with major depression. Biol Psychiatry. 1993 Mar 15;33(6):467-76.

Wu JC, Bunney WE. The biological basis of an antidepressant response to sleep deprivation and relapse: review and hypothesis. Am J Psychiatry. 1990 Jan;147(1):14-21. Review.

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:	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
Study First Received:	April 30, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00670813 History of Changes
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
Physiological Effects of Drugs
Nervous System Diseases
Dyssomnias
Sleep Disorders
Central Nervous System Stimulants
Depressive Disorder
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

Sleep Deprivation
Modafinil
Behavioral Symptoms
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009