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

Cognitive Performance in Major Depression Clinical Trial

— Decoflex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993876
• Other study ID #: KO 2067
• Status: Completed
• Phase: N/A
• First received: October 9, 2009
• Last updated: October 13, 2009
• Start date: August 2005
• Est. completion date: August 2008

Study information

• Verified date: October 2009
• Source: Zentrum für Integrative Psychiatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognitive Performance in Major Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• citalopram
20 to 30 mg per day for 4 weeks
• reboxetine
4 to 8 mg per day for 4 weeks

Behavioral:
• interpersonal psychotherapy

Locations

Country	Name	City	State
Germany	Zentrum für Integrative Psychiatrie	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Zentrum für Integrative Psychiatrie	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive performance with respect to cognitive flexibility, memory and attention		4 weeks	No
Secondary	CREB-phosphorylation in T-Lymphocytes		4 weeks	No