Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil

• Status: Withdrawn
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

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: