Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy
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| First Received Date ICMJE | January 7, 2008 | ||||||||||||||||||||||||||||
| Last Updated Date | October 28, 2011 | ||||||||||||||||||||||||||||
| Start Date ICMJE | January 2000 | ||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00594711 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 | Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy | ||||||||||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Brief Summary | Outcome of psychodynamic psychotherapy measured by [123I] nor-B-CIT SPET imaging Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the treatment of depression. There is evidence that serotonin transporter (SERT) densities are altered in depression. Preliminary observations have suggested that SERT function may recover in connection with dynamic psychotherapy. The objective was to determine whether SERT densities change in relation to clinical recovery during psychodynamic psychotherapy. |
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| Detailed Description | N=26 Method Twenty six drug-naïve currently depressed (moderate/severe) patients with no previous treatment were recruited for the study. The baseline study included a group of 18 healthy controls. The patients were randomised into psychotherapy and waiting-list control groups. For controls, psychotherapy was started after a 6-month waiting period. [123I] nor-B-CIT SPET imaging was performed at baseline and after 12 months of psychotherapy. For the controls, additional imaging was performed after the 6-month waiting period. |
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| Study Type ICMJE | Observational | ||||||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: DNA, creatine, B-vitamin,BP from blood samples. |
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| Sampling Method | Non-Probability Sample | ||||||||||||||||||||||||||||
| Study Population | Patiens of clinic |
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| Condition ICMJE | Depression | ||||||||||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Study Group/Cohort (s) |
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| 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 | 26 | ||||||||||||||||||||||||||||
| Completion Date | December 2008 | ||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||
| Ages | 18 Years to 55 Years | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00594711 | ||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | KUH5703410, 118/9/00 | ||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||
| Responsible Party | Taru Grohn, Kuopio University Hospital | ||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Kuopio University Hospital | ||||||||||||||||||||||||||||
| Collaborators ICMJE | University of Eastern Finland | ||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Kuopio University Hospital | ||||||||||||||||||||||||||||
| Verification Date | October 2011 | ||||||||||||||||||||||||||||
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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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