DepressionPhase 2/3NCT00655057
Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression
A Phase 2/3 study testing S-citalopram, Cognitive behavioral therapy (CBT) and TRODAT-1 single photon emission computed tomographic (SPECT) imaging in people with Depression, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- S-citalopram, Cognitive behavioral therapy (CBT) and TRODAT-1 single photon emission computed tomographic (SPECT) imaging
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD)
- Drug free of psychotropic medication for more than 6 months before study entry
- 17-item Hamilton Depression Scale (HAM-D17) score of greater than 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of study entry
- Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID)
Who cannot join
- DSM-IV Axis I diagnosis other than MDE
- History of mania
- Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry
- History of sensitivity or intolerance to s-citalopram
- Medical contraindication to the use of s-citalopram
- Unstable medical condition (e.g., angina pectoris, untreated hypertension)
Show all 25Show fewer
- Pregnant or breastfeeding
- Woman of childbearing potential not using a medically acceptable form of birth control
- Actively suicidal or requiring hospitalization
- Requiring additional psychotropic drug therapy
- History of transient ischemic attacks
- History of cerebral infarction (including lacunar infarct with symptoms that last more than 24 hours)
- History of Binswanger's disease (or a history of hypertensive encephalopathy)
- History of intracranial hemorrhage
- History of head trauma with loss of consciousness
- History of encephalitis
- History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
- Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
- History of cognitive impairment other than MDE
- History of normal pressure hydrocephalus
- History of cancer metastatic to the central nervous system
- History of Parkinson's disease or other basal ganglia disease
- History of Guillain-Barre syndrome (chronic or relapsing polyneuropathy)
- Inability to undergo an MRI scan
- History of DSM-IV Axis I Mood Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: SPECT Brain Imaging as a Bio-Marker of Major Depression
This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.
Read the detailed description
Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disinterest in previously enjoyed activities, often causing strain on work, social, and family life. A person's depression can be attributed to a variety of causes, including physiological and sociological factors. Among physiological factors, dopamine (DA), a chemical associated with feelings of happiness and pleasure, may play a key role in the onset of depression and may also be involved in the beneficial effect of antidepressant medication. Recent studies have found that people with depression have increased DA transporter (DAT) levels in a specific region of the inner brain called the striatum. The increased DAT levels might reflect alterations in central DA function. Treatment for depression with selective serotonin reuptake inhibitor (SSRI) antidepressant therapy may help in returning DAT levels to normal and in improving depressive symptoms. Using single photon emission computed tomography (SPECT) imaging, this study will examine changes in brain DAT activity in people with depression before and after they receive SSRI antidepressant therapy or cognitive behavioral therapy (CBT).
Participation in this study will last about 14 weeks and will involve participants who are healthy and depressed. All participants will first undergo baseline assessments that will include a medical history, questions about current and past health, a physical exam, a blood draw, a urine sampling, and an electrocardiogram (ECG). After completing the baseline assessments, participants will undergo a TRODAT-1 SPECT scan, which will involve an injection of TRODAT-1 (a radioactive agent to measure DA) and, after a 3-hour break, a 75-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.
Participants with depression will then be assigned randomly to undergo 12 weeks of treatment with either the antidepressant medication s-citalopram or CBT. Participants assigned to take s-citalopram will return for study visits weekly for 2 weeks, every other week for 6 weeks, and then monthly for 4 weeks. During study visits, participants will receive their medication, answer questions about depression and medication side effects, and occasionally fill out general health questionnaires. Participants receiving CBT will attend twice weekly sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. After 12 weeks, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat TRODAT-1 SPECT scan.
- Conditions
- Depression
- Being tested
- S-citalopram, Cognitive behavioral therapy (CBT), TRODAT-1 single photon emission computed tomographic (SPECT) imaging
- Keywords
- Dopamine Transporter, Biomarker, SPECT Brain Imaging, Antidepressant Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-citalopramDrug
Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks.
Cognitive behavioral therapy (CBT)Behavioural
Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression.
TRODAT-1 single photon emission computed tomographic (SPECT) imagingProcedure or surgery
Participants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healthy participants will undergo TRODAT-1 SPECT imaging. Receives: Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging |
| 2 | Experimental | Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram. Receives: Drug: S-citalopram; Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging |
| 3 | Active comparator | Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy. Receives: Behavioral: Cognitive behavioral therapy (CBT); Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dopamine Transporter Binding
Measured: Measured at Weeks 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startOct 2005
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jay D. Amsterdam, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655057
- Sponsor's protocol ID
- R34MH070753
- Other IDs
- R34MH070753, DATR A3-NSS
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2008
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Brain Imaging as a Bio-Marker of Major Depression
- ClinicalTrials.gov ID
- NCT00655057
- Acronym / sponsor ID
- R34MH070753
- Conditions
- Depression
- Keywords
- Dopamine Transporter, Biomarker, SPECT Brain Imaging, Antidepressant Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.
Detailed description
Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disinterest in previously enjoyed activities, often causing strain on work, social, and family life. A person's depression can be attributed to a variety of causes, including physiological and sociological factors. Among physiological factors, dopamine (DA), a chemical associated with feelings of happiness and pleasure, may play a key role in the onset of depression and may also be involved in the beneficial effect of antidepressant medication. Recent studies have found that people with depression have increased DA transporter (DAT) levels in a specific region of the inner brain called the striatum. The increased DAT levels might reflect alterations in central DA function. Treatment for depression with selective serotonin reuptake inhibitor (SSRI) antidepressant therapy may help in returning DAT levels to normal and in improving depressive symptoms. Using single photon emission computed tomography (SPECT) imaging, this study will examine changes in brain DAT activity in people with depression before and after they receive SSRI antidepressant therapy or cognitive behavioral therapy (CBT).
Participation in this study will last about 14 weeks and will involve participants who are healthy and depressed. All participants will first undergo baseline assessments that will include a medical history, questions about current and past health, a physical exam, a blood draw, a urine sampling, and an electrocardiogram (ECG). After completing the baseline assessments, participants will undergo a TRODAT-1 SPECT scan, which will involve an injection of TRODAT-1 (a radioactive agent to measure DA) and, after a 3-hour break, a 75-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.
Participants with depression will then be assigned randomly to undergo 12 weeks of treatment with either the antidepressant medication s-citalopram or CBT. Participants assigned to take s-citalopram will return for study visits weekly for 2 weeks, every other week for 6 weeks, and then monthly for 4 weeks. During study visits, participants will receive their medication, answer questions about depression and medication side effects, and occasionally fill out general health questionnaires. Participants receiving CBT will attend twice weekly sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. After 12 weeks, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat TRODAT-1 SPECT scan.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imagingHealthy participants will undergo TRODAT-1 SPECT imaging. |
| 2 | Experimental | Drug: S-citalopram, Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imagingParticipants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram. |
| 3 | Active comparator | Behavioral: Cognitive behavioral therapy (CBT), Procedure: TRODAT-1 single photon emission computed tomographic (SPECT) imagingParticipants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD)
- Drug free of psychotropic medication for more than 6 months before study entry
- 17-item Hamilton Depression Scale (HAM-D17) score of greater than 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of study entry
- Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID)
Key exclusion criteria (25 listed)
- DSM-IV Axis I diagnosis other than MDE
- History of mania
- Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry
- History of sensitivity or intolerance to s-citalopram
- Medical contraindication to the use of s-citalopram
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 |
|---|---|---|
| S-citalopramParticipants will take 10 to 30 mg of s-citalopram daily for 12 weeks. | Drug | 2 |
| Cognitive behavioral therapy (CBT)Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. | Behavioural | 3 |
| TRODAT-1 single photon emission computed tomographic (SPECT) imagingParticipants' striatal dopamine transporter (DAT) levels will be measured using [99mTc]TRODAT-1 SPECT with magnetic resonance imaging (MRI) co-localization on two separate occasions. Participants with depression will undergo TRODAT-1 SPECT imaging immediately before and after 12 weeks of their assigned treatment. Healthy participants will undergo TRODAT-1 SPECT imaging at baseline and 12 weeks later. | Procedure or surgery | 1, 2, 3 |
Primary outcome
Change in Dopamine Transporter Binding
Time frame: Measured at Weeks 0 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay D. Amsterdam, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing S-citalopram, Cognitive behavioral therapy (CBT) and TRODAT-1 single photon emission computed tomographic (SPECT) imaging in people with Depression, run by University of Pennsylvania 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 5 inclusion and 25 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 16 Apr 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Dopamine Transporter Binding (time frame: Measured at Weeks 0 and 12). 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 16 Apr 2020.