DepressionPhase 4NCT00226642
Treatment of Mild and Subthreshold Depressive Disorders
A Phase 4 study testing Sertralin, Cognitive-behavioral therapy and Non-specific supporting group therapy in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression. Hypotheses: SSRI is superior to placebo CBT is superior to a non-specific supporting group therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Sertralin, Cognitive-behavioral therapy and Non-specific supporting group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
- informed consent
- 18 years
Who cannot join
- severe mood disorders
- bipolar disorder
- recurrent brief depression
- suicidality
- alcohol or drug dependency
- obsessive-compulsive disorder
- schizoaffective disorder / schizophrenia
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl ("Treatment of Mild and Subthreshold Depressive Disorders". A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT")
The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression.
Hypotheses:
- SSRI is superior to placebo
- CBT is superior to a non-specific supporting group therapy
- Conditions
- Depression
- Being tested
- Sertralin, Cognitive-behavioral therapy, Placebo, Non-specific supporting group therapy
- Keywords
- depression, primary care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralinDrug
Cognitive-behavioral therapyBehavioural
PlaceboDrug
Non-specific supporting group therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)
Secondary outcomes (2)
BDI (changes between baseline and individual endpoint)
CGI (changes between baseline and individual endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 369 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Hegerl, Prof, MD, Principal investigator, LMU, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226642
- Sponsor's protocol ID
- KNDS-2.1
- Status last verified
- Feb 2002
- First submitted
- 23 Sep 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
Publications
Mergl R, Allgaier AK, Hautzinger M, Coyne JC, Hegerl U, Henkel V. One-year follow-up of a randomized controlled trial of sertraline and cognitive behavior group therapy in depressed primary care patients (MIND study). J Affect Disord. 2018 Apr 1;230:15-21. doi: 10.1016/j.jad.2017.12.084. Epub 2018 Jan 2.
PubMed 29355727Helmreich I, Wagner S, Mergl R, Allgaier AK, Hautzinger M, Henkel V, Hegerl U, Tadic A. Sensitivity to changes during antidepressant treatment: a comparison of unidimensional subscales of the Inventory of Depressive Symptomatology (IDS-C) and the Hamilton Depression Rating Scale (HAMD) in patients with mild major, minor or subsyndromal depression. Eur Arch Psychiatry Clin Neurosci. 2012 Jun;262(4):291-304. doi: 10.1007/s00406-011-0263-x. Epub 2011 Sep 30.
PubMed 21959915Mergl R, Henkel V, Allgaier AK, Kramer D, Hautzinger M, Kohnen R, Coyne J, Hegerl U. Are treatment preferences relevant in response to serotonergic antidepressants and cognitive-behavioral therapy in depressed primary care patients? Results from a randomized controlled trial including a patients' choice arm. Psychother Psychosom. 2011;80(1):39-47. doi: 10.1159/000318772. Epub 2010 Oct 23.
PubMed 20975325Hegerl U, Hautzinger M, Mergl R, Kohnen R, Schutze M, Scheunemann W, Allgaier AK, Coyne J, Henkel V. Effects of pharmacotherapy and psychotherapy in depressed primary-care patients: a randomized, controlled trial including a patients' choice arm. Int J Neuropsychopharmacol. 2010 Feb;13(1):31-44. doi: 10.1017/S1461145709000224. Epub 2009 Apr 3.
PubMed 19341510
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl ("Treatment of Mild and Subthreshold Depressive Disorders". A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT")
- ClinicalTrials.gov ID
- NCT00226642
- Acronym / sponsor ID
- KNDS-2.1
- Conditions
- Depression
- Keywords
- depression, primary care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 369 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- First posted
- 27 Sep 2005 (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 the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression.
Hypotheses:
- SSRI is superior to placebo
- CBT is superior to a non-specific supporting group therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
- informed consent
- 18 years
Key exclusion criteria (8 listed)
- severe mood disorders
- bipolar disorder
- recurrent brief depression
- suicidality
- alcohol or drug dependency
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 |
|---|---|---|
| Sertralin | Drug | – |
| Cognitive-behavioral therapy | Behavioural | – |
| Placebo | Drug | – |
| Non-specific supporting group therapy | Behavioural | – |
Primary outcome
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)
2 secondary outcomes
BDI (changes between baseline and individual endpoint)
CGI (changes between baseline and individual endpoint)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2005.
- Derived from this study: PubMed 29355727Mergl R, Allgaier AK, Hautzinger M, Coyne JC, Hegerl U, Henkel V. One-year follow-up of a randomized controlled trial of sertraline and cognitive behavior group therapy in depressed primary care patients (MIND study). J Affect Disord. 2018 Apr 1;230:15-21. doi: 10.1016/j.jad.2017.12.084. Epub 2018 Jan 2.
- Derived from this study: PubMed 21959915Helmreich I, Wagner S, Mergl R, Allgaier AK, Hautzinger M, Henkel V, Hegerl U, Tadic A. Sensitivity to changes during antidepressant treatment: a comparison of unidimensional subscales of the Inventory of Depressive Symptomatology (IDS-C) and the Hamilton Depression Rating Scale (HAMD) in patients with mild major, minor or subsyndromal depression. Eur Arch Psychiatry Clin Neurosci. 2012 Jun;262(4):291-304. doi: 10.1007/s00406-011-0263-x. Epub 2011 Sep 30.
- Derived from this study: PubMed 20975325Mergl R, Henkel V, Allgaier AK, Kramer D, Hautzinger M, Kohnen R, Coyne J, Hegerl U. Are treatment preferences relevant in response to serotonergic antidepressants and cognitive-behavioral therapy in depressed primary care patients? Results from a randomized controlled trial including a patients' choice arm. Psychother Psychosom. 2011;80(1):39-47. doi: 10.1159/000318772. Epub 2010 Oct 23.
- Derived from this study: PubMed 19341510Hegerl U, Hautzinger M, Mergl R, Kohnen R, Schutze M, Scheunemann W, Allgaier AK, Coyne J, Henkel V. Effects of pharmacotherapy and psychotherapy in depressed primary-care patients: a randomized, controlled trial including a patients' choice arm. Int J Neuropsychopharmacol. 2010 Feb;13(1):31-44. doi: 10.1017/S1461145709000224. Epub 2009 Apr 3.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Ulrich Hegerl, Prof, MD principal investigator
LMU, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertralin, Cognitive-behavioral therapy and Non-specific supporting group therapy in people with Depression, run by Ludwig-Maximilians - University of Munich 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 8 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 27 Sep 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
HAMD (changes between baseline and individual endpoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226642, which also lists 4 linked publications.
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 27 Sep 2005.