Chronic DepressionGETTYNCT00596986
Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression
A study testing Duloxetine and Cognitive Behavioural Analysis System of Psychotherapy in people with Chronic Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Depression
- What is being tested?
- Duloxetine and Cognitive Behavioural Analysis System of Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Sep 2009
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission)
- HAMD-24>20
Who cannot join
- Concurrent Psychotherapy or Psychopharmacotherapy
- Previous Non-Response to Duloxetine
- Non-Response to three Antidepressants of two different groups given at adequate doses or Non-Response to two empirically tested forms of Psychotherapy in the current Depressive Episode
- Serious Psychiatric comorbidity
- Serious Neurologic comorbidity
- Contraindications to Duloxetine
- Contraindications to fMRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias
The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.
- Conditions
- Chronic Depression
- Being tested
- Duloxetine, Cognitive Behavioural Analysis System of Psychotherapy
- Keywords
- Depression, Duloxetine, Psychotherapy, Magnetic Resonance Imaging
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Duloxetine 30mg up to 120mg per day.
Cognitive Behavioural Analysis System of PsychotherapyBehavioural
Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| AD | Active comparator | Antidepressant Duloxetine Receives: Drug: Duloxetine |
| PT | Active comparator | Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy Receives: Behavioral: Cognitive Behavioural Analysis System of Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging Data (fMRI)
Measured: Before and After Therapy
Secondary outcomes (2)
HAMD
Measured: Weekly
Salivary Cortisol
Measured: Before and After Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Isabella Heuser, Prof. Dr. med. Dipl. Psych., Study chair, Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, GermanyMichael Colla, Dr. med., Principal investigator, Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596986
- Sponsor's protocol ID
- EUK-B2.1
- Other IDs
- EUK-B2
- Acronym
- GETTY
- Status last verified
- Jul 2009
- First submitted
- 8 Jan 2008
- Last updated
- 3 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias
- ClinicalTrials.gov ID
- NCT00596986
- Acronym / sponsor ID
- GETTY / EUK-B2.1
- Conditions
- Chronic Depression
- Keywords
- Depression, Duloxetine, Psychotherapy, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (estimated)
- First posted
- 17 Jan 2008 (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.
The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD | Active comparator | Drug: DuloxetineAntidepressant Duloxetine |
| PT | Active comparator | Behavioral: Cognitive Behavioural Analysis System of PsychotherapyPsychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission)
- HAMD-24>20
Key exclusion criteria (7 listed)
- Concurrent Psychotherapy or Psychopharmacotherapy
- Previous Non-Response to Duloxetine
- Non-Response to three Antidepressants of two different groups given at adequate doses or Non-Response to two empirically tested forms of Psychotherapy in the current Depressive Episode
- Serious Psychiatric comorbidity
- Serious Neurologic comorbidity
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 |
|---|---|---|
| DuloxetineDuloxetine 30mg up to 120mg per day. | Drug | AD |
| Cognitive Behavioural Analysis System of PsychotherapyCognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions. | Behavioural | PT |
Primary outcome
Neuroimaging Data (fMRI)
Time frame: Before and After Therapy
2 secondary outcomes
HAMD
Time frame: Weekly
Salivary Cortisol
Time frame: Before and After Therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
Related trials for Chronic Depression
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Application of Meaning-Based Psychotherapy to a Sample of Patients With Chronic Pain
Chronic Pain
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
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.
Isabella Heuser, Prof. Dr. med. Dipl. Psych. study chair
Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
Michael Colla, Dr. med. principal investigator
Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, 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 Duloxetine and Cognitive Behavioural Analysis System of Psychotherapy in people with Chronic Depression, run by Charite University, Berlin, Germany 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Aug 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?
Results are not available in the source record.
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?
Neuroimaging Data (fMRI) (time frame: Before and After Therapy). 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 3 Aug 2009.