Major Depressive DisorderNCT01701141
Depression and Dopamine Transporter Function Study Using C-11 Altropane
An observational study of Major Depressive Disorder and Anhedonia, run by Mclean Hospital at 2 sites in United States.
Trial summary
Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to modulate behavior as a function of rewards. However, the neurobiology of anhedonia and reduced reward responsiveness remains largely unknown. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Anhedonia
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community Sample
Who may be able to join
- Written informed consent;
- Both genders and all ethnic origins, age between 18 and 45;
- Right-handed (Chapman and Chapman 1987);
- Absence of any medications for at least 3 weeks;
- Absence of pregnancy;
- Absence of current drug use (cocaine, cannabinoids, opiates, amphetamines, benzodiazepines and barbiturates) as assessed by urinary drug test.
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- For women, completion of a negative urine pregnancy test prior to the MRI scan, as well as a negative STAT quantitative serum hCG test immediately prior to radiopharmaceutical exposure;
- Normal or corrected-to-normal vision and hearing.
- DSM-IV diagnostic criteria for MDD (diagnosed with the use of the SCID);
- A baseline HRSD score (Hamilton 1960) greater than or equal to 16 (17-item version);
- Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP);
- Absence of any medications for at least 3 weeks;
Who cannot join
- Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- History or current serious or unstable medical illness, including cancer, cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of seizure disorder;
- Failure to meet standard PET safety requirements;
- Failure to meet standard fMRI safety requirements;
- Students and employees supervised by the Investigators at MGH, McLean Hospital and Harvard University;
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- Absence of fluency in written and spoken English;
- History of head injury;
- History or current use of cocaine, stimulants, or other dopaminergic drugs.
- Diabetes with poor glucose control;
- History or current diagnosis of dementia, or a score of < 26 on the Mini Mental Status Examination (Folstein, 1975) at the screening visit;
- Clinical or laboratory evidence of hypothyroidism or currently taking thyroid medication;
- Currently taking medication that affects blood flow, e.g. certain blood pressure medications
- Evidence of significant inconsistencies in self-report.
- Criteria Specific to MDD subjects
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment;
- History or current diagnosis of: learning and developmental disorders (including ADHD and autism spectrum disorders), anorexia nervosa, cognitive disorders, somatoform and factitious disorders, dissociative disorders, personality disorders, organic mental disorders, schizophrenia or other psychotic disorder, bipolar disorder, obsessive compulsive disorder; simple phobia, social anxiety disorder and generalized anxiety disorder are allowed if secondary to MDD.
- History of substance dependence lifetime or substance abuse within the last 12 months;
- History of bulimia nervosa or PTSD within the past 2 years;
- History or current diagnosis of dementia, or a score of < 26 on the Mini Mental Status Examination (Folstein, 1975) at the screening visit;
- Current use of other psychotropic drugs;
- Patients with lifetime electroconvulsive therapy (ECT);
- Presence of any psychotropic medications for at least 2 weeks:
- 6 months for dopaminergic drugs (including methylphenidate),
- 6 weeks for fluoxetine,
- 6 months for neuroleptics,
- 2 weeks for benzodiazepines,
- 2 weeks for any other antidepressants.
- Criteria Specific to Control subjects
- History or current diagnosis of any of DSM-IV psychiatric illness;
- First degree relative with mood disorder or psychosis;
- History or current use of any psychiatric medication.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Depression and Dopamine Transporter Function: A Positron Emission Tomography Study Using C-11 Altropane
Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to modulate behavior as a function of rewards. However, the neurobiology of anhedonia and reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a critical role in goal-directed behavior and reinforcement learning, DA dysregulation might play an important role. In fact, several lines of evidence suggest that down-regulation of DA transmission might characterize depression vulnerability and the emergence of depressive symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward learning in the probabilistic reward task, and abnormal functional magnetic resonance imaging (fMRI) activation in dorsal and ventral striatal regions during an instrumental learning task.
This study will include three sessions.
Read more
The first will take place at Massachusetts General Hospital or at McLean Hospital's Center for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain the study; (b) collect written informed consent, and (c) assess the subject's eligibility.
Following this, another session (either second or third in order) will take place at the MGH PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward task designed to measure reward learning and sensitivity to reward. The radioactive tracer utilized is 11C-altropane.
Another session (either second or third in order) will take place at the McLean Hospital Neuroimaging Center. Participants will complete an instrumental learning task while in the fMRI, followed by a social reinforcement learning task and an implicit learning serial reaction time task upon completion of the scan. In the instrumental learning task, participants have the opportunity to earn money but need to learn, by trial and error, stimulus-outcome associations. The social reinforcement learning task is designed to investigate whether learning deficits in MDD are specific to learning from monetary incentives or whether the learning deficits are more global and are affected when learning from social rewards and punishments. Participants will also complete an implicit learning serial reaction time task, designed to exclude the possibility of global learning deficits in MDD.
- Conditions
- Major Depressive Disorder, Anhedonia
- Keywords
- Positron Emission Tomography (PET), Magnetic resonance imaging (MRI), reward, stress, learning, Major Depressive Disorder, Anhedonia
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with MDD | Individuals with current MDD as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment. | |
| Healthy Controls | Individuals with no psychiatric diagnosis as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-Altropane Binding
11C-altropane binding is recording during the positron emission tomography (PET) scan and is used to measure dopamine transporter levels.
Measured: 1 hour long PET scan during session 2
Behavioral Performance in Probabilistic Reward Task
The probabilistic reward task is designed to measure sensitivity to reward and reward learning.
Measured: 20 minute task administered during session 2
Brain Activity during Instrumental Learning Task
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
Measured: 30 minute long fMRI scan during session 3
Behavioral Performance in Instrumental Learning Task
The instrumental learning task is designed to measure participant learning from reward and punishment.
Measured: 30 minute task administered during session 3
Behavioral Performance in the Social Reinforcement Learning Task
The social reinforcement learning task is designed to investigate whether learning deficits in MDD are specific to learning from monetary incentives or whether the learning deficits are more global and are affected when learning from social rewards and punishments.
Measured: 15 minute task administered during session 3
Secondary outcomes (2)
Questionnaire Data
At all sessions participants will fill out self-report questionnaires regarding aspects of mood and affect, demographics, caffeine and alcohol consumption, etc.
Measured: Self-report measures are administered at all 3 sessions which take place within an average of 2-3 weeks
Behavioral Performance in Implicit Learning Serial Reaction Time Task
The implicit learning serial reaction time task is designed to exclude the possibility of global learning deficits in major depressive disorder.
Measured: 5 minute task administered during session 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego A. Pizzagalli, Mclean Hospital
- Investigators
- Diego Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701141
- Sponsor's protocol ID
- 2009-P-001360
- Status last verified
- May 2018
- First submitted
- 2 Oct 2012
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Dopamine Transporter Function: A Positron Emission Tomography Study Using C-11 Altropane
- ClinicalTrials.gov ID
- NCT01701141
- Acronym / sponsor ID
- 2009-P-001360
- Conditions
- Major Depressive Disorder, Anhedonia
- Keywords
- Positron Emission Tomography (PET), Magnetic resonance imaging (MRI), reward, stress, learning, Major Depressive Disorder, Anhedonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Oct 2012 (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.
Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to modulate behavior as a function of rewards. However, the neurobiology of anhedonia and reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a critical role in goal-directed behavior and reinforcement learning, DA dysregulation might play an important role. In fact, several lines of evidence suggest that down-regulation of DA transmission might characterize depression vulnerability and the emergence of depressive symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward learning in the probabilistic reward task, and abnormal functional magnetic resonance imaging (fMRI) activation in dorsal and ventral striatal regions during an instrumental learning task.
This study will include three sessions.
The first will take place at Massachusetts General Hospital or at McLean Hospital's Center for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain the study; (b) collect written informed consent, and (c) assess the subject's eligibility.
Following this, another session (either second or third in order) will take place at the MGH PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward task designed to measure reward learning and sensitivity to reward. The radioactive tracer utilized is 11C-altropane.
Another session (either second or third in order) will take place at the McLean Hospital Neuroimaging Center. Participants will complete an instrumental learning task while in the fMRI, followed by a social reinforcement learning task and an implicit learning serial reaction time task upon completion of the scan. In the instrumental learning task, participants have the opportunity to earn money but need to learn, by trial and error, stimulus-outcome associations. The social reinforcement learning task is designed to investigate whether learning deficits in MDD are specific to learning from monetary incentives or whether the learning deficits are more global and are affected when learning from social rewards and punishments. Participants will also complete an implicit learning serial reaction time task, designed to exclude the possibility of global learning deficits in MDD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with MDD | – | –Individuals with current MDD as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment. |
| Healthy Controls | – | –Individuals with no psychiatric diagnosis as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (12 listed)
- Written informed consent;
- Both genders and all ethnic origins, age between 18 and 45;
- Right-handed (Chapman and Chapman 1987);
- Absence of any medications for at least 3 weeks;
- Absence of pregnancy;
Key exclusion criteria (32 listed)
- Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- History or current serious or unstable medical illness, including cancer, cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of seizure disorder;
- Failure to meet standard PET safety requirements;
- Failure to meet standard fMRI safety requirements;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
11C-Altropane Binding
Time frame: 1 hour long PET scan during session 2
11C-altropane binding is recording during the positron emission tomography (PET) scan and is used to measure dopamine transporter levels.
Behavioral Performance in Probabilistic Reward Task
Time frame: 20 minute task administered during session 2
The probabilistic reward task is designed to measure sensitivity to reward and reward learning.
Brain Activity during Instrumental Learning Task
Time frame: 30 minute long fMRI scan during session 3
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
Behavioral Performance in Instrumental Learning Task
Time frame: 30 minute task administered during session 3
The instrumental learning task is designed to measure participant learning from reward and punishment.
Behavioral Performance in the Social Reinforcement Learning Task
Time frame: 15 minute task administered during session 3
The social reinforcement learning task is designed to investigate whether learning deficits in MDD are specific to learning from monetary incentives or whether the learning deficits are more global and are affected when learning from social rewards and punishments.
2 secondary outcomes
Questionnaire Data
Time frame: Self-report measures are administered at all 3 sessions which take place within an average of 2-3 weeks
Behavioral Performance in Implicit Learning Serial Reaction Time Task
Time frame: 5 minute task administered during session 3
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 21 May 2018.
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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.
Diego Pizzagalli, PhD principal investigator
Mclean Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Anhedonia, run by Mclean Hospital at 2 sites 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 12 inclusion and 32 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
11C-Altropane Binding (time frame: 1 hour long PET scan during session 2). The study lists 5 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 21 May 2018.