Major Depressive DisorderPhase 2STAPMDDTDMNCT02473783
The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
A Phase 2 study testing Sertraline HCl and I-123-ADAM SPECT in people with Major Depressive Disorder, run by Tri-Service General Hospital (TSGH).
Trial summary
Objectives: 1. To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl 2. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sertraline HCl and I-123-ADAM SPECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Nov 2012
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For MDD subjects
- Subject meets the DSM-IV criteria for MDD
- Subject has a minimum score of 18 on the 17-item HAMD total score
- Subject has a minimum score of 2 on item 1, depressed mood, of HAMD
- Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives
- For healthy subjects
- Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination
- Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study
Who cannot join
- Subject with history of any co-morbid neuropsychiatric disease
- Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication
- Subject with history of alcohol or substance dependence or abuse
- Subject with allergic history to the investigational products
- Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study
- Subject with malignancy within past 5 years
Show all 11Show fewer
- Subject with any diseases judged by investigators as inappropriate for this study
- Female subject being pregnant, nursing, or lactating
- Female subject of childbearing potential not using a medically acceptable form of birth control
- Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations
- Subject participated in any investigational drug trial within 4 weeks before entering this study
About this study
Official title: An I-123-ADAM SPECT Imaging Study to Evaluate the Serotonin Transporter (SERT) Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Assisting in Detecting MDD
Objectives:
- To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl
- To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD
- To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects
- To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects
- To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl
Read the detailed description
Background:
Serotonin transporter (SERT) plays an important role in the pathophysiology of psychiatric disorders such as anxiety and depression and is the primary target of the selective serotonin reuptake inhibitors (SSRIs) which are posited to exert their effect in treating psychiatric disorders aforementioned by this mechanism. I-123-ADAM is a selective radioligand for imaging SERT using SPECT. Research showed that it displayed an extremely high binding affinity to SERT sites. Previous literature also suggested the potential role of I-123-ADAM SPECT as useful in understanding how serotonin system affected depression. This study aims to evaluate the SERT availability by means of I-123-ADAM SPECT imaging study in drug-free subjects for prognosing MDD treatment and assisting in detecting MDD.
Methods:
We enrolled patients who had major depressive disorder but was free from prior antidepressant medication for at least 5 times of elimination half-lives and healthy controls. The patients with major depressive disorder (N=20) received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. All healthy subjects (N=17) had only basal I-123-ADAM SPECT. The relationship between improvement of depressive symptoms and basal SERT availability for the prognosis of MDD subjects being treated with Sertraline HCl will be analyzed. In addition, the association between the efficacy of treatment with Sertraline HCl and the change of SERT availability will also be investigated. The control group were selected in order to distinguish the difference of basal SERT binding potential of I-123-ADAM between healthy and MDD subjects.
- Conditions
- Major Depressive Disorder
- Being tested
- Sertraline HCl, I-123-ADAM SPECT
- 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.
Sertraline HClDrug
Also called Zoloft
The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECTOther
The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed. Receives: Drug: Sertraline HCl; Other: I-123-ADAM SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
Measured: 6 weeks (The Healthy control Group only had the scanning at baseline)
Secondary outcomes (2)
Hamilton Depression Rating Scale (HAM-D) Total Scores
The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.
Measured: 6 weeks
Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.
Measured: assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Atomic Research Institute, Taiwan
- Responsible party
- Principal investigator, Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital (TSGH)
- Investigators
- Chin-Bin Yeh, M.D., Ph.D., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473783
- Sponsor's protocol ID
- INEI-1A20090409
- Acronym
- STAPMDDTDM
- Status last verified
- Dec 2017
- First submitted
- 11 Jun 2015
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An I-123-ADAM SPECT Imaging Study to Evaluate the Serotonin Transporter (SERT) Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Assisting in Detecting MDD
- ClinicalTrials.gov ID
- NCT02473783
- Acronym / sponsor ID
- STAPMDDTDM / INEI-1A20090409
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- National Atomic Research Institute, Taiwan
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Posted 21 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl
- To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD
- To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects
- To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects
- To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl
Detailed description
Background:
Serotonin transporter (SERT) plays an important role in the pathophysiology of psychiatric disorders such as anxiety and depression and is the primary target of the selective serotonin reuptake inhibitors (SSRIs) which are posited to exert their effect in treating psychiatric disorders aforementioned by this mechanism. I-123-ADAM is a selective radioligand for imaging SERT using SPECT. Research showed that it displayed an extremely high binding affinity to SERT sites. Previous literature also suggested the potential role of I-123-ADAM SPECT as useful in understanding how serotonin system affected depression. This study aims to evaluate the SERT availability by means of I-123-ADAM SPECT imaging study in drug-free subjects for prognosing MDD treatment and assisting in detecting MDD.
Methods:
We enrolled patients who had major depressive disorder but was free from prior antidepressant medication for at least 5 times of elimination half-lives and healthy controls. The patients with major depressive disorder (N=20) received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. All healthy subjects (N=17) had only basal I-123-ADAM SPECT. The relationship between improvement of depressive symptoms and basal SERT availability for the prognosis of MDD subjects being treated with Sertraline HCl will be analyzed. In addition, the association between the efficacy of treatment with Sertraline HCl and the change of SERT availability will also be investigated. The control group were selected in order to distinguish the difference of basal SERT binding potential of I-123-ADAM between healthy and MDD subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Sertraline HCl, Other: I-123-ADAM SPECTThe subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For MDD subjects
- Subject meets the DSM-IV criteria for MDD
- Subject has a minimum score of 18 on the 17-item HAMD total score
- Subject has a minimum score of 2 on item 1, depressed mood, of HAMD
- Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives
Key exclusion criteria (11 listed)
- Subject with history of any co-morbid neuropsychiatric disease
- Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication
- Subject with history of alcohol or substance dependence or abuse
- Subject with allergic history to the investigational products
- Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study
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 |
|---|---|---|
| Sertraline HClAlso: ZoloftThe regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks. | Drug | Treatment Group |
| I-123-ADAM SPECTThe subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection. | Other | Treatment Group |
Primary outcome
The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
Time frame: 6 weeks (The Healthy control Group only had the scanning at baseline)
Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
2 secondary outcomes
Hamilton Depression Rating Scale (HAM-D) Total Scores
Time frame: 6 weeks
Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
Time frame: assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- 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.
Chin-Bin Yeh, M.D., Ph.D. principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline HCl and I-123-ADAM SPECT in people with Major Depressive Disorder, run by Tri-Service General Hospital (TSGH).
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 8 inclusion and 11 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 19 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2017). 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?
The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed) (time frame: 6 weeks (The Healthy control Group only had the scanning at baseline)). 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 19 Jan 2018.