Status:
WITHDRAWN
Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Cephalon
Conditions:
Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Detailed Description
In about 60 % of depressed patients, sleep deprivation has an acute therapeutic effect. The effect appears within very few hours; this is different from all other antidepressant treatments. However, i...
Eligibility Criteria
Inclusion
- 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
- 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:
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00670813
Start Date
May 1 2008
End Date
November 1 2009
Last Update
July 20 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Sleep Disorders of the Department of Psychiatry and Psychotherapy
Munich, Germany, 81675