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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT00993876
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

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: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CREB-phosphorylation in T-Lymphocytes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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)
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

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).

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993876

Locations
Germany
Zentrum für Integrative Psychiatrie
Kiel, Germany, 24105
Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
German Research Foundation
Investigators
Principal Investigator: Jakob M. Koch, M.D. Zentrum für Integrative Psychiatrie, Kiel, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00993876     History of Changes
Other Study ID Numbers: KO 2067
Study First Received: October 9, 2009
Last Updated: October 13, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Zentrum für Integrative Psychiatrie:
Depression
CREB
cognitive performance
 psychotherapy
SSRI
SNRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Reboxetine
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013