DepressionPhase 1NCT01528241
Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
A Phase 1 study testing ABP688 in people with Depression, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
This study is designed to characterize the regional distribution of [11C] ABP688 in brain by positron emission tomography (PET). Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- ABP688
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to May 2010
- Phase
- Phase 1
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 55-80 (inclusive)
- Subjects in good health
- At screening:
- oral body temperature between 35-37.5C
- systolic blood pressure: 90-140 mm Hg
- diastolic blood pressure: 50-90 mm Hg
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- pulse rate: 40-90 bpm
- Female subjects of child bearing potential must have been using a double-barrier local contraception
- Postmenopausal women must have had no menstrual bleeding
- Subjects must have weighed at least 50 kg
- All subjects must provide informed consent
- All subjects must have been able to communicate well with investigator
- Specific to Major depression disorder (MDD)
- Patients had to show following level of symptomatology:
- HAM-D (17-item scale) > 16
- CGI > 4 (moderately ill)
Who cannot join
- Specific criteria for healthy volunteers:
- Presence and/or history of clinically significant major neurological or psychiatric disorder
- Specific criteria for MDD patients:
- Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
- Axis I co-morbidity was excluded except anxiety spectrum disorders
- Criteria for both:
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- Smokers
- Pregnancy
- Subjects with history of or symptoms/complaints consistent with mild cognitive impairment
- Use of any psychotropic prescription drugs
- Coffee consumers more than 6 cups/day
- Participation in any clinical investigation
- Donation or loss of 400 mL or more of blood
- Significant illness within 2 weeks prior to dosing
- A known hypersensitivity to study drug
- MRI scan that showed evidence of stroke
- Any surgical or medical condition which might have significantly altered distribution
- Clinical evidence of any abnormal lab value
- History of immunodeficiency disease
- Positive Hepatitis B surface antigen
- Presence of contraindications to PET scan investigations- Presence of contraindications to MRI investigations
- Evidence from an Allen test of incomplete communication
- History of drug or alcohol abuse
- Current use of anticonvulsant
- Significant radiation exposure
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
New York, New York
Novartis Investigative Site
Pittsburgh, Pennsylvania
About this study
Official title: A Multi-center, Open-label Study in Elderly Healthy Volunteers and Elderly Patients With Major Depressive Disorder to Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
This study is designed to characterize the regional distribution of [11C] ABP688 in brain by positron emission tomography (PET).
- Conditions
- Depression
- Being tested
- ABP688
- Keywords
- ABP688, Tracer, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP688Drug
Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
| Study group | Role | What they receive |
|---|---|---|
| ABP688 | Experimental | Elderly MDD patients and demography matched healthy volunteer Receives: Drug: ABP688 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding of [11C] ABP688 to mGlu5 receptors
Binding of [11C]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes
Measured: Day 1
Blood levels of [11C] ABP688
Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of [11C] ABP688. Specific times are recorded at the clinical site.
Measured: Day 1, up to 60 minutes
Secondary outcomes (1)
Difference in [11C]ABP688 binding to mGlu5 receptors
Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528241
- Sponsor's protocol ID
- CABP688A2102
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study in Elderly Healthy Volunteers and Elderly Patients With Major Depressive Disorder to Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT01528241
- Acronym / sponsor ID
- CABP688A2102
- Conditions
- Depression
- Keywords
- ABP688, Tracer, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Feb 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 is designed to characterize the regional distribution of [11C] ABP688 in brain by positron emission tomography (PET).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABP688 | Experimental | Drug: ABP688Elderly MDD patients and demography matched healthy volunteer |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female subjects 55-80 (inclusive)
- Subjects in good health
- oral body temperature between 35-37.5C
- systolic blood pressure: 90-140 mm Hg
- diastolic blood pressure: 50-90 mm Hg
Key exclusion criteria (26 listed)
- Presence and/or history of clinically significant major neurological or psychiatric disorder
- Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
- Axis I co-morbidity was excluded except anxiety spectrum disorders
- Smokers
- Pregnancy
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 |
|---|---|---|
| ABP688Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push. | Drug | ABP688 |
Primary outcome
Binding of [11C] ABP688 to mGlu5 receptors
Time frame: Day 1
Binding of [11C]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes
Blood levels of [11C] ABP688
Time frame: Day 1, up to 60 minutes
Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of [11C] ABP688. Specific times are recorded at the clinical site.
1 secondary outcome
Difference in [11C]ABP688 binding to mGlu5 receptors
Time frame: Day 1
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 8 Dec 2020.
- Results for CABP688A2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABP688 in people with Depression, run by Novartis Pharmaceuticals 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 16 inclusion and 26 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 8 Dec 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Binding of [11C] ABP688 to mGlu5 receptors (time frame: Day 1). The study lists 2 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 8 Dec 2020.