Clinical trial NCT00993876: Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment
Official title: Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance in Major Depression
Keywords: Depression
CREB
cognitive performance
psychotherapy
SSRI
SNRI
Lead sponsor: Zentrum für Integrative Psychiatrie
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2009-10-14
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: We randomly assigned forty-five depressive patients to one of three treatment groups (Citalopram, Reboxetin or interpersonal psychotherapy (IPT)). At baseline, day 7 and day 28 we assessed the severity of depression and the cognitive performance with respect to cognitive flexibility, memory and attention. We measured pCREB with an enzyme linked immuno sorbent assay (ELISA).

Eligibility criteria: 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

Primary outcomes:
measure: cognitive performance with respect to cognitive flexibility, memory and attention
timeFrame: 4 weeks
Secondary outcomes:
measure: CREB-phosphorylation in T-Lymphocytes
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Zentrum für Integrative Psychiatrie
Study officials:
affiliation: Zentrum für Integrative Psychiatrie, Kiel, Germany
name: Jakob M. Koch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: