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

Primary Purpose

Cognitive Performance in Major Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
citalopram
reboxetine
interpersonal psychotherapy
Sponsored by
Zentrum für Integrative Psychiatrie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Performance in Major Depression focused on measuring Depression, CREB, cognitive performance, psychotherapy, SSRI, SNRI

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentrum für Integrative Psychiatrie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Selective serotonin reuptake inhibitor (SSRI)

Serotonin-norepinephrine reuptake inhibitor (SNRI)

IPT

Arm Description

citalopram

reboxetine

interpersonal psychotherapy

Outcomes

Primary Outcome Measures

cognitive performance with respect to cognitive flexibility, memory and attention

Secondary Outcome Measures

CREB-phosphorylation in T-Lymphocytes

Full Information

First Posted
October 9, 2009
Last Updated
October 13, 2009
Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00993876
Brief Title
Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment
Acronym
Decoflex
Official Title
Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Performance in Major Depression
Keywords
Depression, CREB, cognitive performance, psychotherapy, SSRI, SNRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective serotonin reuptake inhibitor (SSRI)
Arm Type
Experimental
Arm Description
citalopram
Arm Title
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Arm Type
Experimental
Arm Description
reboxetine
Arm Title
IPT
Arm Type
Active Comparator
Arm Description
interpersonal psychotherapy
Intervention Type
Drug
Intervention Name(s)
citalopram
Intervention Description
20 to 30 mg per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
reboxetine
Intervention Description
4 to 8 mg per day for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
interpersonal psychotherapy
Primary Outcome Measure Information:
Title
cognitive performance with respect to cognitive flexibility, memory and attention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
CREB-phosphorylation in T-Lymphocytes
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob M. Koch, M.D.
Organizational Affiliation
Zentrum für Integrative Psychiatrie, Kiel, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Integrative Psychiatrie
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

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

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