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

This study has been completed.
German Research Foundation
Information provided by:
Zentrum für Integrative Psychiatrie Identifier:
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
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 Intervention
Cognitive Performance in Major Depression Drug: citalopram Drug: reboxetine Behavioral: interpersonal psychotherapy

Study Type: Interventional
Study Design: 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

Further study details as provided by Zentrum für Integrative Psychiatrie:

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

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

Enrollment: 45
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00993876

Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
German Research Foundation
Principal Investigator: Jakob M. Koch, M.D. Zentrum für Integrative Psychiatrie, Kiel, Germany
  More Information Identifier: NCT00993876     History of Changes
Other Study ID Numbers: KO 2067
Study First Received: October 9, 2009
Last Updated: October 13, 2009

Keywords provided by Zentrum für Integrative Psychiatrie:
cognitive performance

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adrenergic Uptake Inhibitors processed this record on September 21, 2017