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Completed

NCT Number: NCT00993876

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

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.

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Key information

Conditions

Cognitive Performance in Major Depression Behavior Behavioral Symptoms Depression

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Integrative Psychiatrie

Kiel, 24105, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram

Drug

20 to 30 mg per day for 4 weeks

reboxetine

Drug

4 to 8 mg per day for 4 weeks

interpersonal psychotherapy

Behavioral

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

Sponsors and collaborators

Lead sponsor

Zentrum für Integrative Psychiatrie

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments

Acronym: Decoflex

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 14, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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