Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil -a double blind, randomized, placebo-controlled, monocentric phase II study

Phase 1

• Conditions: Inpatients of the Psychiatric Hospital of the Technical University of MunichDiagnoses:- Depressive episode with somatic symptoms (ICD-10: F32.01, F32.11, F32.21)- Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21)- Bipolar affective disorder, presently depressive episode with somatic syndrome (F31.31, F31.41)Age 18 – 70 yearsHamilton Depression Score (HAMD-21) at baseline > 18

• Registration Number: EUCTR2005-003196-21-DE
• Lead Sponsor: Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-27
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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)
- Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21)
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of psychotic symptoms
Substance dependence (history or present)
Present psychiatric comorbidity
Relevant medical conditions
Acute suicidality
History of seizures
Paroxysmal EEG activity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified