Beta-CIT-SPECT and Neurophysiology in Depression
This study has been completed.
Sponsor:
Ludwig-Maximilians - University of Munich
Collaborator:
H. Lundbeck A/S
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00145132
First received: September 1, 2005
Last updated: June 1, 2010
Last verified: May 2010
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | June 1, 2010 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
changes in β-CIT/neurophysiological measurements from baseline to week 4 [ Time Frame: two assessments, at baseline and week 4 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
changes in β-CIT/neurophysiological measurements from baseline to week 4 | ||||
| Change History | Complete list of historical versions of study NCT00145132 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Beta-CIT-SPECT and Neurophysiology in Depression | ||||
| Official Title ICMJE | Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram | ||||
| Brief Summary | Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Procedure: β-CIT-SPECT, Neurophysiology
β-CIT-SPECT scans and EEG recordings, two assessments each |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00145132 | ||||
| Other Study ID Numbers ICMJE | ESCIT-SPECT-Pogarell, EK287/98 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Oliver Pogarell, MD, University of Munich | ||||
| Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | ||||
| Collaborators ICMJE | H. Lundbeck A/S | ||||
| Investigators ICMJE |
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| Information Provided By | Ludwig-Maximilians - University of Munich | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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