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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00993876
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
German Research Foundation
Information provided by:
Zentrum für Integrative Psychiatrie

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.

Condition or disease Intervention/treatment Phase
Cognitive Performance in Major Depression Drug: citalopram Drug: reboxetine Behavioral: interpersonal psychotherapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
Study Start Date : August 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Selective serotonin reuptake inhibitor (SSRI)
Drug: citalopram
20 to 30 mg per day for 4 weeks

Experimental: Serotonin-norepinephrine reuptake inhibitor (SNRI)
Drug: reboxetine
4 to 8 mg per day for 4 weeks

Active Comparator: IPT
interpersonal psychotherapy
Behavioral: interpersonal psychotherapy

Primary Outcome Measures :
  1. cognitive performance with respect to cognitive flexibility, memory and attention [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. CREB-phosphorylation in T-Lymphocytes [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00993876

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Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
German Research Foundation
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Principal Investigator: Jakob M. Koch, M.D. Zentrum für Integrative Psychiatrie, Kiel, Germany
Layout table for additonal information Identifier: NCT00993876    
Other Study ID Numbers: KO 2067
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009
Keywords provided by Zentrum für Integrative Psychiatrie:
cognitive performance
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Adrenergic Uptake Inhibitors
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Adrenergic Agents