Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment (Decoflex)

Zentrum für Integrative Psychiatrie

Status: Completed

Conditions: Cognitive Performance in Major Depression

Treatments: Behavioral: interpersonal psychotherapy; Drug: citalopram; Drug: reboxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00993876

KO 2067

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Selective serotonin reuptake inhibitor (SSRI)

Experimental group

Description:

citalopram

Treatment:

Drug: citalopram

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Experimental group

Description:

reboxetine

Treatment:

Drug: reboxetine

IPT

Active Comparator group

Description:

interpersonal psychotherapy

Treatment:

Behavioral: interpersonal psychotherapy