Cognitive Performance in Major Depression Clinical Trial
— DecoflexOfficial title:
Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
Verified date | October 2009 |
Source | Zentrum für Integrative Psychiatrie |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Cognitive deficits in major depression seem explicable by the well-recognized concept of impaired neuroplasticity in mood disorders. This concept initially emerged from preclinical evidence that antidepressants phosphorylate and therefore activate the cyclic AMP response element binding protein (CREB) that is essential for synaptic plasticity. Nevertheless, the question remains whether the activation of CREB by antidepressants is relevant for the remission of cognitive deficits in patients. We addressed this issue by investigating the cognitive improvement during treatment with either citalopram or reboxetine because these antidepressants are different in their capacity to increase phosphorylated CREB (pCREB). Besides the pharmacological treatment groups, another group of patients was treated exclusively with psychotherapy.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Diagnosed according DSM-IV criteria as suffering from major depressive disorder - A baseline score of at least 18 in the Hamilton Depression Scale (HAMD) - No psychopharmacological treatment at least one week prior inclusion or 3 days wash-out Exclusion Criteria: - Severe depressive episode and/or psychotic depressive episode Axis I disorder: - Substance-related Disorders - Psychotic Disorders - Dementia or other cognitive Disorders - Obsessive-Compulsive Disorders Axis II disorder: • Borderline Personality Disorder Axis III disorder: - Infectious Diseases - Cancer - Endocrinological Diseases - Hematological Diseases - Autoimmune Diseases |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Zentrum für Integrative Psychiatrie | Kiel |
Lead Sponsor | Collaborator |
---|---|
Zentrum für Integrative Psychiatrie | German Research Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cognitive performance with respect to cognitive flexibility, memory and attention | 4 weeks | No | |
Secondary | CREB-phosphorylation in T-Lymphocytes | 4 weeks | No |