Major Depressive DisorderNCT00609453
Brain Imaging of Psychotherapy for Depression
A study testing Brief Behavioral Activation Treatment for Depression in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brief Behavioral Activation Treatment for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For group 1: Diagnosis of current depression and no other current Axis I psychiatric disorder
- For group 1: Hamilton Depression Rating Scale score of 15 or greater
Who cannot join
- A history of serious head injury or neurological disease or psychosis
- Current use of psychoactive medications
- Factors that could affect MRI safety including current or planned pregnancy
- For group 2: current Axis I psychiatric disorder, as assessed by structured clinical interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke-UNC Brain Imaging and Analysis Center
Durham, North Carolina, 27710
About this study
Official title: Brain Imaging of Psychotherapy for Depression (Includes, "Reward System Recovery Following Behavioral Activation Therapy in Depression")
The goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group.
- Conditions
- Major Depressive Disorder
- Being tested
- Brief Behavioral Activation Treatment for Depression
- Keywords
- Control participants
- 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.
Brief Behavioral Activation Treatment for DepressionBehavioural
Weekly individual therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Individuals with major depressive disorder receiving therapy Receives: Behavioral: Brief Behavioral Activation Treatment for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Inventory
Measured: three times over 12 weeks
Functional Magnetic Resonance Imaging
Measured: twice in 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionJan 2008
- Study completionJan 2008
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.
- More trials run by University of North Carolina, Chapel HillThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Dichter, University of North Carolina, Chapel Hill
- Investigators
- Gabriel S Dichter, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609453
- Sponsor's protocol ID
- 05-2605
- Other IDs
- NIMH R03 MH078145
- Status last verified
- Oct 2012
- First submitted
- 24 Jan 2008
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of Psychotherapy for Depression (Includes, "Reward System Recovery Following Behavioral Activation Therapy in Depression")
- ClinicalTrials.gov ID
- NCT00609453
- Acronym / sponsor ID
- 05-2605
- Conditions
- Major Depressive Disorder
- Keywords
- Control participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Feb 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 goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief Behavioral Activation Treatment for DepressionIndividuals with major depressive disorder receiving therapy |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- For group 1: Diagnosis of current depression and no other current Axis I psychiatric disorder
- For group 1: Hamilton Depression Rating Scale score of 15 or greater
Key exclusion criteria (4 listed)
- A history of serious head injury or neurological disease or psychosis
- Current use of psychoactive medications
- Factors that could affect MRI safety including current or planned pregnancy
- For group 2: current Axis I psychiatric disorder, as assessed by structured clinical interview
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 |
|---|---|---|
| Brief Behavioral Activation Treatment for DepressionWeekly individual therapy sessions | Behavioural | 1 |
Primary outcome
Hamilton Depression Inventory
Time frame: three times over 12 weeks
Functional Magnetic Resonance Imaging
Time frame: twice in 12 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 8 Oct 2012.
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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.
Gabriel S Dichter, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation Treatment for Depression in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 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 8 Oct 2012. 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 United States. 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?
Hamilton Depression Inventory (time frame: three times over 12 weeks). 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?
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 8 Oct 2012.