MelancholiaPhase 2NCT01548937
Serotonin Transporter Density in Late-life Depression With and Without Dementia
A Phase 2 study testing I-123 ADAM in people with Melancholia, run by Chang Gung Memorial Hospital.
Trial summary
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Melancholia
- What is being tested?
- I-123 ADAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Dec 2012
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be enrolled in the AD depressive group if they:
- Are males or females at least 50 years of age;
- Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
- Meet the NINCDS/ADRDA(National institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association) criteria for probable AD
- A Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
- Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).
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- Patients may be enrolled in the cognitively depressive group if they:
- Are males or females at least 50 years of age;
- Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
- Memory function above the lower normal limits (i.e. 1.5 SD above the mean) on tests for episodic memory.
- Clinical Dementia Rating = 0. Memory Box score must be 0.
- Cognitively normal, based on an absence of significant impairment in cognitive functions or ADL.
- A MMSE score at screening > 24 for those with education level of 6 years or above and > 17 for those are illiterate;
- Give informed consent.
Who cannot join
- Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
- Conditions affecting brain structure or function (e.g., stroke, diabetes, head trauma, depression) or use of cognitively
- Substance abuse.
- Alcohol dependence
About this study
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
This study is expected to be completed in a period of 3 years.
Read the detailed description
Depression and dementia are the two common psychiatric disorders in the elder subjects. Alzheimer's disease (AD) is the most frequent cause of dementia and about 20% of them have depression. Depression subjects are associated with more rapid cognitive decline, a poorer response to treatment. Post mortem study showed close relationship between AD and disruptions of the serotonergic system, including loss of serotnergic neurons at brain stem. However, the alternations in presynaptic serotonin function relative to demented or non-demented subjects remain to be investigated in living subjects. In this study, the investigators will collect 40 elder subjects (i.e., age above or equal to 50 years old). The serotonin transporter activity will be compared between subjects with or without dementia using I-123 ADAM images. The single photon emission tomography (SPECT) will be compared to recent (within 6 months) F-18 FDG PET images for further investigation.
- Conditions
- Melancholia
- Being tested
- I-123 ADAM
- Keywords
- I-123 ADAM Serotonin transporter imaging
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-123 ADAMDrug
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
| Study group | Role | What they receive |
|---|---|---|
| I-123 ADAM | Experimental | I-123 ADAM Serotonin transporter imaging Receives: Drug: I-123 ADAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia.
To expand the database of I-123 ADAM SPECT imaging in AD depressive and cognitively depressive patients to refine the definition of a positive scan in patient with AD and MDD.
Measured: three years
Secondary outcomes (1)
Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.
To expand the safety database of I-123 ADAM SPECT imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelancholiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548937
- Sponsor's protocol ID
- 98-2132A
- Status last verified
- Jan 2016
- First submitted
- 29 Dec 2011
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin Transporter Density in Late-life Depression With and Without Dementia
- ClinicalTrials.gov ID
- NCT01548937
- Acronym / sponsor ID
- 98-2132A
- Conditions
- Melancholia
- Keywords
- I-123 ADAM Serotonin transporter imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Mar 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.
This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
This study is expected to be completed in a period of 3 years.
Detailed description
Depression and dementia are the two common psychiatric disorders in the elder subjects. Alzheimer's disease (AD) is the most frequent cause of dementia and about 20% of them have depression. Depression subjects are associated with more rapid cognitive decline, a poorer response to treatment. Post mortem study showed close relationship between AD and disruptions of the serotonergic system, including loss of serotnergic neurons at brain stem. However, the alternations in presynaptic serotonin function relative to demented or non-demented subjects remain to be investigated in living subjects. In this study, the investigators will collect 40 elder subjects (i.e., age above or equal to 50 years old). The serotonin transporter activity will be compared between subjects with or without dementia using I-123 ADAM images. The single photon emission tomography (SPECT) will be compared to recent (within 6 months) F-18 FDG PET images for further investigation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-123 ADAM | Experimental | Drug: I-123 ADAMI-123 ADAM Serotonin transporter imaging |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients may be enrolled in the AD depressive group if they:
- Patients may be enrolled in the cognitively depressive group if they:
Key exclusion criteria (4 listed)
- Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
- Conditions affecting brain structure or function (e.g., stroke, diabetes, head trauma, depression) or use of cognitively
- Substance abuse.
- Alcohol dependence
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 |
|---|---|---|
| I-123 ADAMThis study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events. | Drug | I-123 ADAM |
Primary outcome
Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia.
Time frame: three years
To expand the database of I-123 ADAM SPECT imaging in AD depressive and cognitively depressive patients to refine the definition of a positive scan in patient with AD and MDD.
1 secondary outcome
Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.
Time frame: three years
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 28 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-123 ADAM in people with Melancholia, run by Chang Gung Memorial Hospital.
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 14 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 28 Jan 2016. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia. (time frame: three years). 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 28 Jan 2016.