Major Depressive DisorderNCT00714779
Fluoxetine vs. Brief Psychotherapy for Major Depression
A study testing Fluoxetine and Short-term psychodynamic psychotherapy in people with Major Depressive Disorder, run by University of Turku.
Trial summary
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fluoxetine and Short-term psychodynamic psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2004
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MDD (mild to moderate)
- HDRS 15 or more, age 20-60 years
- No treatment for preceding 4 months
- No DSM-IV axis I or II comorbidity
- No severe somatic illness
- No contraindications for fluoxetine treatment
Who cannot join
None listed.
About this study
Official title: Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.
Read the detailed description
This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.
- Conditions
- Major Depressive Disorder
- Being tested
- Fluoxetine, Short-term psychodynamic psychotherapy
- Keywords
- Major depressive Disorder, fluoxetine, short-term psychodynamic psychotherapy, PET
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
20-40 mg / day orally
Short-term psychodynamic psychotherapyBehavioural
1 session / week for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fluoxetine Receives: Drug: Fluoxetine |
| 2 | Active comparator | Short-term psychodynamic psychotherapy Receives: Behavioral: Short-term psychodynamic psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D
Measured: 0, 16 weeks, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJan 2000
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- KELA, Finnish State Grant
- Investigators
- Hasse Karlsson, MA, MD, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714779
- Sponsor's protocol ID
- HK123
- Status last verified
- Jul 2008
- First submitted
- 7 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT00714779
- Acronym / sponsor ID
- HK123
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive Disorder, fluoxetine, short-term psychodynamic psychotherapy, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- KELA, Finnish State Grant
- Study start
- Jan 2000
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 14 Jul 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.
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.
Detailed description
This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: FluoxetineFluoxetine |
| 2 | Active comparator | Behavioral: Short-term psychodynamic psychotherapyShort-term psychodynamic psychotherapy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- MDD (mild to moderate)
- HDRS 15 or more, age 20-60 years
- No treatment for preceding 4 months
- No DSM-IV axis I or II comorbidity
- No severe somatic illness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fluoxetine20-40 mg / day orally | Drug | 1 |
| Short-term psychodynamic psychotherapy1 session / week for 16 weeks | Behavioural | 2 |
Primary outcome
HAM-D
Time frame: 0, 16 weeks, one year
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 Jul 2008.
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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.
Hasse Karlsson, MA, MD, PhD principal investigator
University of Helsinki
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine and Short-term psychodynamic psychotherapy in people with Major Depressive Disorder, run by University of Turku.
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 6 inclusion and 0 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 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
HAM-D (time frame: 0, 16 weeks, one year). 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 Jul 2008.