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Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy

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ClinicalTrials.gov Identifier: NCT00594711
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : October 31, 2011
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by (Responsible Party):
Taru Grohn, Kuopio University Hospital

Tracking Information
First Submitted Date January 7, 2008
First Posted Date January 16, 2008
Last Update Posted Date October 31, 2011
Study Start Date January 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00594711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy
Official Title 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.

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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, creatine, B-vitamin,BP from blood samples.
Sampling Method Non-Probability Sample
Study Population Patiens of clinic
Condition Depression
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Case-group
  • 2
    Control-group
Publications * Joensuu M, Ahola P, Knekt P, Lindfors O, Saarinen P, Tolmunen T, Valkonen-Korhonen M, Vanninen R, Jääskeläinen T, Virtala E, Kuikka J, Tiihonen J, Lehtonen J. Baseline symptom severity predicts serotonin transporter change during psychotherapy in patients with major depression. Psychiatry Clin Neurosci. 2016 Jan;70(1):34-41. doi: 10.1111/pcn.12335. Epub 2015 Sep 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January¬†15,¬†2008)
26
Original Actual Enrollment Same as current
Actual Study Completion Date December 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • depression

Exclusion Criteria:

  • antidepressive medication
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00594711
Other Study ID Numbers KUH5703410
118/9/00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Taru Grohn, Kuopio University Hospital
Study Sponsor Kuopio University Hospital
Collaborators University of Eastern Finland
Investigators
Principal Investigator: Pirjo Saarinen, Ph.D. Kuopio University Hospital
Study Director: Johannes Lehtonen, Ph.D Kuopio University Hospital
Study Chair: Lehto Soili, MD Kuopio University Hospital
Study Chair: Minna Valkonen-Korhonen, Ph.D Kuopio University
Study Chair: Pasi Ahola, MD Kuopio University
Study Chair: Mikko Joensuu, MD Kuopio University Hospital
Study Chair: Tommi Tolmunen, Ph.D. Kuopio University Hospital
PRS Account Kuopio University Hospital
Verification Date October 2011