DepressionPhase 2/3NCT00641108
Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression
A Phase 2/3 study testing ADAM SPECT plus Cognitive Therapy and ADAM SPECT plus No Therapy in people with Depression, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral 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?
- ADAM SPECT plus Cognitive Therapy and ADAM SPECT plus No Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2011
- 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 disorder (MDD)
- Drug naive from prior psychotropic medication for more than 6 months before study entry
- Hamilton-Depression (HAM-D) 17 score greater than or equal to 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of scanning
Who cannot join
- DSM-IV Axis I diagnosis other than MDD
- Use of psychotropic medication within 6 months of study entry
- History of bipolar disorder
- Current alcohol or drug abuse/dependence within 6 months of study entry
- History of sensitivity or intolerance to s-citalopram
- Medical contraindication to the use of s-citalopram
Show all 25Show fewer
- Unstable medical condition (e.g., angina pectoris, untreated hypertension)
- Pregnant or nursing
- 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 more than 24 hours in duration)
- 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 major depressive episode
- History of normal pressure hydrocephalus
- History of cancer metastatic to the central nervous system
- History of Parkinson's or other basal ganglia disease
- History of Guillain-Barré syndrome (chronic or relapsing polyneuropathy)
- Inability to undergo an MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309
About this study
Official title: Effect of Psychotherapy on Brain Serotonin Activity
This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral therapy.
Read the detailed description
Depression is a serious illness that affects almost 19 million adults in the United States each year. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. A person's depression can be attributed to a variety of causes, including biological and genetic factors, environmental influences, or developmental experiences. Among biological factors, a recently researched possible cause is the altered activity of specialized areas on brain nerve cells called serotonin receptors, which have been found to be at reduced levels in people with depression. The hormone serotonin is known to naturally influence mood, making depression treatments that aim to increase levels of serotonin important. Treatment for depression with cognitive behavioral therapy (CBT), which teaches ways to modify thoughts and behaviors that contribute to depression, may help in raising brain serotonin levels and in improving depressive symptoms. This study will examine changes in brain serotonin activity using single photon emission computed tomography (SPECT) imaging in people with depression before and after they receive CBT. The study will also use SPECT imaging to compare brain serotonin activity of non-depressed healthy participants with that of depressed participants.
Participation in this study will last between 12 and 14 weeks. All participants will first undergo an initial evaluation that will include questions about medical history, a physical exam, a blood draw, a urine test, and an electrocardiogram (ECG). Participants will then undergo an ADAM (a selective radioligand for SPECT imaging) SPECT scan. During the ADAM SPECT scan visit, participants will undergo an injection of the ADAM, an ECG, blood pressure monitoring, and a 60-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.
Depressed participants will then attend at least once weekly CBT sessions for 12 weeks. During the 45-minute sessions, participants will meet with a therapist to learn ways to adjust thoughts and behaviors that may be adding to their depression. After completing the 12 weeks of CBT, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat ADAM SPECT scan.
- Conditions
- Depression
- Being tested
- ADAM SPECT plus Cognitive Therapy, ADAM SPECT plus No Therapy
- Keywords
- SPECT Brain Imaging, Cognitive Therapy, Serotonin Transporter Binding, Predictive Biomarker
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAM SPECT plus Cognitive TherapyDrug
ADAM SPECT plus No TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| ADAM SPECT | Experimental | Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy. Receives: Drug: ADAM SPECT plus Cognitive Therapy |
| Control | Active comparator | Healthy subjects without depression will undergo ADAM SPECT scans. Receives: Drug: ADAM SPECT plus No Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serotonin Transporter Availability
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 posted21 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- Robert J. DeRubeis, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641108
- Sponsor's protocol ID
- R34MH077580
- Other IDs
- R34MH077580, DATR A5-ETMA
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 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
- Effect of Psychotherapy on Brain Serotonin Activity
- ClinicalTrials.gov ID
- NCT00641108
- Acronym / sponsor ID
- R34MH077580
- Conditions
- Depression
- Keywords
- SPECT Brain Imaging, Cognitive Therapy, Serotonin Transporter Binding, Predictive Biomarker
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Mar 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 serotonin activity in people with depression before and after they receive cognitive behavioral therapy.
Detailed description
Depression is a serious illness that affects almost 19 million adults in the United States each year. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. A person's depression can be attributed to a variety of causes, including biological and genetic factors, environmental influences, or developmental experiences. Among biological factors, a recently researched possible cause is the altered activity of specialized areas on brain nerve cells called serotonin receptors, which have been found to be at reduced levels in people with depression. The hormone serotonin is known to naturally influence mood, making depression treatments that aim to increase levels of serotonin important. Treatment for depression with cognitive behavioral therapy (CBT), which teaches ways to modify thoughts and behaviors that contribute to depression, may help in raising brain serotonin levels and in improving depressive symptoms. This study will examine changes in brain serotonin activity using single photon emission computed tomography (SPECT) imaging in people with depression before and after they receive CBT. The study will also use SPECT imaging to compare brain serotonin activity of non-depressed healthy participants with that of depressed participants.
Participation in this study will last between 12 and 14 weeks. All participants will first undergo an initial evaluation that will include questions about medical history, a physical exam, a blood draw, a urine test, and an electrocardiogram (ECG). Participants will then undergo an ADAM (a selective radioligand for SPECT imaging) SPECT scan. During the ADAM SPECT scan visit, participants will undergo an injection of the ADAM, an ECG, blood pressure monitoring, and a 60-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.
Depressed participants will then attend at least once weekly CBT sessions for 12 weeks. During the 45-minute sessions, participants will meet with a therapist to learn ways to adjust thoughts and behaviors that may be adding to their depression. After completing the 12 weeks of CBT, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat ADAM SPECT scan.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADAM SPECT | Experimental | Drug: ADAM SPECT plus Cognitive TherapyParticipants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy. |
| Control | Active comparator | Drug: ADAM SPECT plus No TherapyHealthy subjects without depression will undergo ADAM SPECT scans. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of major depressive disorder (MDD)
- Drug naive from prior psychotropic medication for more than 6 months before study entry
- Hamilton-Depression (HAM-D) 17 score greater than or equal to 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of scanning
Key exclusion criteria (25 listed)
- DSM-IV Axis I diagnosis other than MDD
- Use of psychotropic medication within 6 months of study entry
- History of bipolar disorder
- Current alcohol or drug abuse/dependence within 6 months of study entry
- History of sensitivity or intolerance to 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 |
|---|---|---|
| ADAM SPECT plus Cognitive Therapy | Drug | ADAM SPECT |
| ADAM SPECT plus No Therapy | Drug | Control |
Primary outcome
Change in Serotonin Transporter Availability
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.
Robert J. DeRubeis, PhD 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 ADAM SPECT plus Cognitive Therapy and ADAM SPECT plus No Therapy 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 4 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 Serotonin Transporter Availability (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.