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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cognitive Performance in Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Selective serotonin reuptake inhibitor (SSRI)

citalopram

Group Type EXPERIMENTAL

citalopram

Intervention Type DRUG

20 to 30 mg per day for 4 weeks

Serotonin-norepinephrine reuptake inhibitor (SNRI)

reboxetine

Group Type EXPERIMENTAL

reboxetine

Intervention Type DRUG

4 to 8 mg per day for 4 weeks

IPT

interpersonal psychotherapy

Group Type ACTIVE_COMPARATOR

interpersonal psychotherapy

Intervention Type BEHAVIORAL

Interventions

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citalopram

20 to 30 mg per day for 4 weeks

Intervention Type DRUG

reboxetine

4 to 8 mg per day for 4 weeks

Intervention Type DRUG

interpersonal psychotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No