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CompletedNCT00993876DecoflexUpdated Oct 14, 2009

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

An interventional study of citalopram and reboxetine in Cognitive Performance in Major Depression, sponsored by Zentrum für Integrative Psychiatrie. Completed at 1 site in Germany. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-10-14.

Sponsored by Zentrum für Integrative Psychiatrie · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cognitive Performance in Major Depression

Keywords

  • Depression
  • CREB
  • cognitive performance
  • psychotherapy
  • SSRI
  • SNRI
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 45 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Zentrum für Integrative Psychiatrie is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Selective serotonin reuptake inhibitor (SSRI)

    citalopram

    Drug: citalopram

  • Experimental
    Serotonin-norepinephrine reuptake inhibitor (SNRI)

    reboxetine

    Drug: reboxetine

  • Active comparator
    IPT

    interpersonal psychotherapy

    Behavioral: interpersonal psychotherapy

Interventions

  • Drugcitalopram

    20 to 30 mg per day for 4 weeks

  • Drugreboxetine

    4 to 8 mg per day for 4 weeks

  • Behavioralinterpersonal psychotherapy
06

What researchers measure

Primary outcomes

  1. cognitive performance with respect to cognitive flexibility, memory and attention

    Time frame: 4 weeks

Secondary outcomes

  1. CREB-phosphorylation in T-Lymphocytes

    Time frame: 4 weeks

07

Study locations

1 site
  • Zentrum für Integrative Psychiatrie
    Kiel, 24105, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00993876
Lead sponsor
Zentrum für Integrative Psychiatrie
Collaborators
German Research Foundation
First posted
Oct 14, 2009
Start date
Aug 2005
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Oct 14, 2009

Study contacts

Jakob M. Koch, M.D.
principal investigator · Zentrum für Integrative Psychiatrie, Kiel, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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