Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil

NCT00670813 | Withdrawn Phase 2 DMC

• 2 other identifiers: SE03EudraCT Nr. 2005-003196-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; (total) sleep deprivation; Modafinil; polysomnography sleep

Outcome Measures

Primary Outcomes (1)

• Improvement on the Hamilton Depression Scale (6-Item Version) from Baseline to Follow-up

  Baseline, 24 h (after sleep deprivation night), 48 h (after the first recovery night)

Secondary Outcomes (4)

• Number of responders (50% reduction on the HAMD-6) in the modafinil group versus the placebo group

  Baseline, 24 h (after sleep deprivation night), 48 h (after the first recovery night)

• self-rating scale of global mental state (Befindlichkeitsskala (Bf-s)) and the Stanford Sleepiness Scale.

  Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night)

• Polysomnography (among others assessing sleep onset latency, sleep efficiency, sleep states, wakefulness after sleep onset)

  Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night)

• Neuropsychological battery (including Zahlenverbindungstest, California Verbal Learning Test, d2 Attention Stress Test, Farb-Wort-Interferenztest, CS fine motor task

  Baseline 24 h (after sleep deprivation night), 48 h (after the first recovery night)

Study Arms (2)

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)

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

Interventions

Modafinil (Vigil) DRUG

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

Modafinil (Vigil)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Technical University of Munich: lead
• Cephalon: collaborator

Study Sites (1)

Centre for Sleep Disorders of the Department of Psychiatry and Psychotherapy

Munich, 81675, Germany

Location

Related Publications (10)

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

  PMID: 12531127 BACKGROUND

• 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. doi: 10.1002/da.1045.

  PMID: 11568981 BACKGROUND

• 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. doi: 10.1016/s0006-3223(97)00297-7.

  PMID: 9611673 BACKGROUND

• Ringel BL, Szuba MP. Potential mechanisms of the sleep therapies for depression. Depress Anxiety. 2001;14(1):29-36. doi: 10.1002/da.1044.

  PMID: 11568980 BACKGROUND

• 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. doi: 10.1016/s0006-3223(99)00125-0.

  PMID: 10459393 BACKGROUND

• 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. doi: 10.1016/0006-3223(93)90175-d.

  PMID: 8490073 BACKGROUND

• 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. doi: 10.1176/ajp.147.1.14.

  PMID: 2403471 BACKGROUND

• Kasper S, Möller HJ (eds). Therapeutischer Schlafentzug. Klinik und Wirkmechanismen. Wien New York: Springer, 1996

  BACKGROUND

• Wiegand MH. Schlaf, Schlafentzug und Depression. Experimentelle Studien zum therapeutischen Schlafentzug. Berlin Heidelberg New York: Springer, 1995

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression; Sleep Deprivation

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael H Wiegand, Prof. Dr.med. Dipl. Psych.

  Head of the Centre for Sleep Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 20, 2011

Record last verified: 2008-04

Locations

DE (1)