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

October 13, 2009 updated by: Zentrum für Integrative Psychiatrie

Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Zentrum für Integrative Psychiatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selective serotonin reuptake inhibitor (SSRI)
citalopram
Drug: citalopram
20 to 30 mg per day for 4 weeks
Experimental: Serotonin-norepinephrine reuptake inhibitor (SNRI)
reboxetine
Drug: reboxetine
4 to 8 mg per day for 4 weeks
Active Comparator: IPT
interpersonal psychotherapy
Behavioral: interpersonal psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive performance with respect to cognitive flexibility, memory and attention
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CREB-phosphorylation in T-Lymphocytes
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zentrum für Integrative Psychiatrie

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Jakob M. Koch, M.D., Zentrum für Integrative Psychiatrie, Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KO 2067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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