Cognitive Performance in Major DepressionDecoflexNCT00993876
Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment
A study testing citalopram, reboxetine and interpersonal psychotherapy in people with Cognitive Performance in Major Depression, run by Zentrum für Integrative Psychiatrie at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Cognitive Performance in Major Depression
- What is being tested?
- citalopram, reboxetine and interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Severe depressive episode and/or psychotic depressive episode
- Axis I disorder:
- Substance-related Disorders
- Psychotic Disorders
- Dementia or other cognitive Disorders
- Obsessive-Compulsive Disorders
Show all 14Show fewer
- Axis II disorder:
- Borderline Personality Disorder
- Axis III disorder:
- Infectious Diseases
- Cancer
- Endocrinological Diseases
- Hematological Diseases
- Autoimmune Diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
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).
- Being tested
- citalopram, reboxetine, interpersonal psychotherapy
- Keywords
- Depression, CREB, cognitive performance, psychotherapy, SSRI, SNRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
20 to 30 mg per day for 4 weeks
reboxetineDrug
4 to 8 mg per day for 4 weeks
interpersonal psychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Selective serotonin reuptake inhibitor (SSRI) | Experimental | citalopram Receives: Drug: citalopram |
| Serotonin-norepinephrine reuptake inhibitor (SNRI) | Experimental | reboxetine Receives: Drug: reboxetine |
| IPT | Active comparator | interpersonal psychotherapy Receives: Behavioral: interpersonal psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive performance with respect to cognitive flexibility, memory and attention
Measured: 4 weeks
Secondary outcomes (1)
CREB-phosphorylation in T-Lymphocytes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startAug 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Performance in Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentrum für Integrative Psychiatrie
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Jakob M. Koch, M.D., Principal investigator, Zentrum für Integrative Psychiatrie, Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993876
- Sponsor's protocol ID
- KO 2067
- Acronym
- Decoflex
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Flexibility and Its Correlation to Sleep and Neuroplasticity In The Course Of Depression During Different Treatments
- ClinicalTrials.gov ID
- NCT00993876
- Acronym / sponsor ID
- Decoflex / KO 2067
- Keywords
- Depression, CREB, cognitive performance, psychotherapy, SSRI, SNRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zentrum für Integrative PsychiatrieUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Aug 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Selective serotonin reuptake inhibitor (SSRI) | Experimental | Drug: citalopramcitalopram |
| Serotonin-norepinephrine reuptake inhibitor (SNRI) | Experimental | Drug: reboxetinereboxetine |
| IPT | Active comparator | Behavioral: interpersonal psychotherapyinterpersonal psychotherapy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Severe depressive episode and/or psychotic depressive episode
- Substance-related Disorders
- Psychotic Disorders
- Dementia or other cognitive Disorders
- Obsessive-Compulsive Disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citalopram20 to 30 mg per day for 4 weeks | Drug | Selective serotonin reuptake inhibitor (SSRI) |
| reboxetine4 to 8 mg per day for 4 weeks | Drug | Serotonin-norepinephrine reuptake inhibitor (SNRI) |
| interpersonal psychotherapy | Behavioural | IPT |
Primary outcome
cognitive performance with respect to cognitive flexibility, memory and attention
Time frame: 4 weeks
1 secondary outcome
CREB-phosphorylation in T-Lymphocytes
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob M. Koch, M.D. principal investigator
Zentrum für Integrative Psychiatrie, Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citalopram, reboxetine and interpersonal psychotherapy in people with Cognitive Performance in Major Depression, run by Zentrum für Integrative Psychiatrie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive performance with respect to cognitive flexibility, memory and attention (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009.