Chronic DepressionPhase 3NCT00837564
Cognitive Behavioural Analysis System of Psychotherapy (CBASp) Versus Escitalopram in Chronic Depression
A Phase 3 study testing CBASP psychotherapy and Escitalopram in people with Chronic Depression, run by University Hospital Freiburg at 2 sites in Germany.
Trial summary
60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Depression
- What is being tested?
- CBASP psychotherapy and Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2009to Apr 2011
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode)
- Age 18-65
- Score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)
Who cannot join
- Acute risk for suicide
- History of psychotic symptoms, bipolar disorder or dementia
- Severe substance-related abuse or dependence disorder
- Schizotypal, antisocial or borderline personality disorder
- Serious medical condition
- Severe cognitive impairment
Show all 9Show fewer
- Absence of a response to previous adequate trial of the study medication/CBASP
- Hypersensitivity to Escitalopram
- Treatment with a MAO-inhibitor within 1 week before the initiation of study treatment
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University of Bonn, Dept. of Psychiatry
Bonn, D-53105
Dieter Schoepf, MD, dieter.schoepf@ukb.uni-bonn.de
Dieter Schoepf, MD
- Recruiting
University of Freiburg, Dept. of Psychiatry and Psychotherapy
Freiburg im Breisgau, D-79104
Claus Normann, MD, +49-761-2706501, claus.normann@uniklinik-freiburg.de
Claus Normann, MD
About this study
Official title: Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma
60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks.
Read the detailed description
The psychotherapeutic treatment with CBASP will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. The starting dose for Escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. The dosage can be reduced to 10 mg/d after day 7 to improve tolerance. Th MADRS-scale is the primary outcome measure; ratings will be performed by a blinded rater. If there is no improvement (reduction of less than 20% of the MADRS), patients will be crossed over in terms of adding the other treatment at week 8. Study patients will be asked to participate in fMRI, genetic and pharmacological substudies.
- Conditions
- Chronic Depression
- Being tested
- CBASP psychotherapy, Escitalopram
- Keywords
- chronic depression, CBASP, Escitalopram, depression, trauma
- Medical subject headings
- Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBASP psychotherapyOther
specific psychotherapy for chronic depression
EscitalopramDrug
Escitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management
| Study group | Role | What they receive |
|---|---|---|
| CBASP | Experimental | CBASP psychotherapy Receives: Other: CBASP psychotherapy |
| Escitalopram | Experimental | Escitalopram pharmacotherapy and clinical management Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
Measured: 8 weeks
Secondary outcomes (1)
Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization
Measured: 28 weeks after ranomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2011 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn
- Investigators
- Claus Normann, MD, Principal investigator, University of Freiburg, Dep. of PsychiatryDieter Schoepf, MD, Principal investigator, University of Bonn, Clinic for Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837564
- Sponsor's protocol ID
- CBASP-1
- Status last verified
- Jul 2010
- First submitted
- 4 Feb 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma
- ClinicalTrials.gov ID
- NCT00837564
- Acronym / sponsor ID
- CBASP-1
- Conditions
- Chronic Depression
- Keywords
- chronic depression, CBASP, Escitalopram, depression, trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- University Hospital, Bonn
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 5 Feb 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.
60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks.
Detailed description
The psychotherapeutic treatment with CBASP will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. The starting dose for Escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. The dosage can be reduced to 10 mg/d after day 7 to improve tolerance. Th MADRS-scale is the primary outcome measure; ratings will be performed by a blinded rater. If there is no improvement (reduction of less than 20% of the MADRS), patients will be crossed over in terms of adding the other treatment at week 8. Study patients will be asked to participate in fMRI, genetic and pharmacological substudies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBASP | Experimental | Other: CBASP psychotherapyCBASP psychotherapy |
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram pharmacotherapy and clinical management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode)
- Age 18-65
- Score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)
Key exclusion criteria (9 listed)
- Acute risk for suicide
- History of psychotic symptoms, bipolar disorder or dementia
- Severe substance-related abuse or dependence disorder
- Schizotypal, antisocial or borderline personality disorder
- Serious medical condition
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 |
|---|---|---|
| CBASP psychotherapyspecific psychotherapy for chronic depression | Other | CBASP |
| EscitalopramEscitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management | Drug | Escitalopram |
Primary outcome
Depressive symptomatology after 8 weeks after randomization as measured by the MADRS
Time frame: 8 weeks
1 secondary outcome
Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization
Time frame: 28 weeks after ranomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
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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.
University of Freiburg, Dept. of Psychiatry and Psychotherapy
Freiburg im Breisgau, Germany
Claus Normann, MD principal investigator
University of Freiburg, Dep. of Psychiatry
Dieter Schoepf, MD principal investigator
University of Bonn, Clinic for Psychiatry and Psychotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CBASP psychotherapy and Escitalopram in people with Chronic Depression, run by University Hospital Freiburg at 2 sites 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 9 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 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptomatology after 8 weeks after randomization as measured by the MADRS (time frame: 8 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 30 Jun 2010.