Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment
Decoflex
Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedOctober 14, 2009
October 1, 2009
3 years
October 9, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cognitive performance with respect to cognitive flexibility, memory and attention
4 weeks
Secondary Outcomes (1)
CREB-phosphorylation in T-Lymphocytes
4 weeks
Study Arms (3)
Selective serotonin reuptake inhibitor (SSRI)
EXPERIMENTALcitalopram
Serotonin-norepinephrine reuptake inhibitor (SNRI)
EXPERIMENTALreboxetine
IPT
ACTIVE COMPARATORinterpersonal psychotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed according DSM-IV criteria as suffering from major depressive disorder
- A baseline score of at least 18 in the Hamilton Depression Scale (HAMD)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zentrum für Integrative Psychiatrielead
- German Research Foundationcollaborator
Study Sites (1)
Zentrum für Integrative Psychiatrie
Kiel, 24105, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakob M. Koch, M.D.
Zentrum für Integrative Psychiatrie, Kiel, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 14, 2009
Study Start
August 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
October 14, 2009
Record last verified: 2009-10