Depression Clinical Trial
— PsySysNeOfficial title:
Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
Verified date | November 2017 |
Source | University of Eastern Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.
Status | Completed |
Enrollment | 82 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18-65 - Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period Exclusion Criteria: - Psychotic disorder - Bipolar disorder - Current substance abuse (excluding nicotine) |
Country | Name | City | State |
---|---|---|---|
Finland | University of Eastern Finland | Kuopio | North Savo |
Lead Sponsor | Collaborator |
---|---|
University of Eastern Finland | Jyväskylä Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Neurophysiological measurements. | eeg | At baseline and after intervention (5 mos) | |
Primary | Depression | Montgomery-Åsberg Depression Rating Scale | At baseline and after intervention (at 5 months) | |
Secondary | Peripheral blood biomarkers | Blood samples are collected before and after intervention. | At baseline and after intervention (at 5 mos) |
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