Major Depressive Disorder PatientsPhase 1NCT01903200
Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder
A Phase 1 study testing FK949E in people with Major Depressive Disorder Patients, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Major Depressive Disorder Patients
- What is being tested?
- FK949E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2010to Sep 2011
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of major depressive disorder according to the DSM-IV-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders version-4) criteria for any of the following:
- In case of not receiving antidepressant treatment: Patients with a diagnosis within 6 months prior to provision of written informed consent
- In case of receiving antidepressant treatment: Patients continuously receiving antidepressant treatment at the time of providing written informed consent
- Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study
- Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator
Who cannot join
- A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to the study
- Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status
- A history of substance or alcohol abuse or dependence excluding caffeine and nicotine
- Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to the start of study drug administration and throughout the study period
- Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier)
- Patients with any diagnosis of a neurological condition, such as Parkinson's disease, Huntington's disease, essential tremor, multiple sclerosis, prior brain injury, space occupying lesion, etc.
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- A clinical finding that is unstable (e.g., hypertension, unstable angina) or that, in the opinion of the investigator or sub-investigator, would be negatively affected by the study medication or that would affect the study medication
- A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless it has been in remission for at least 5 years.
- Conditions that could affect absorption and metabolism of study medication (e.g., malabsorption syndrome, liver disease).
- A current or past diagnosis of transient ischemic attack (TIA)
- A history of seizure disorder, except for febrile convulsions
- Receipt of electroconvulsive therapy within 90 days prior to the start of study drug administration
- Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to the start of study drug administration and throughout the study period
- Patients who, in the investigator's opinion, would require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy had been ongoing for a minimum of 90 days
- before study drug administration
- A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months, and those judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator
- A current or past history of diabetes mellitus* or glycated hemoglobin (HbA1c) of ≥ 6.5% at screening within 2 months before the start of study drug administration (*refer to the guidelines for monitoring blood glucose levels in patients treated with atypical antipsychotics)
- A white blood cell count (WBC) of ≤ 3,000/mm3 at screening assessment
- Elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values at screening assessment (grade 2 or higher according to the "Criteria for Classification of the Grade of Adverse Drug Reactions to Pharmaceutical Products" (Pharmaceutical Affairs Bureau Safety Division's Notification No. 80 issued on 29 June 1992))
- A known history of hypersensitivity to quetiapine or to any other component in the FK949E tablets at the time of providing written informed consent
- Treatment with quetiapine for depressive symptoms or bipolar disorder (mania) at the time of providing written informed consent
- Participation in another clinical study or post-marketing study within 12 weeks prior to the start of study drug administration
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder
The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD).
- Conditions
- Major Depressive Disorder Patients
- Being tested
- FK949E
- Keywords
- Antipsychotic, FK949E, Quetiapine, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK949EDrug
Also called extended release formulation of quetiapine
Oral
| Study group | Role | What they receive |
|---|---|---|
| FK949E Fed Group | Experimental | FK949E is administered after breakfast Receives: Drug: FK949E |
| FK949E Fasted Group | Experimental | FK949E is administered in the morning under fasting conditions Receives: Drug: FK949E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of unchanged quetiapine
Measured: For 24 hours after dosing.
AUC (area under the curve) of unchanged quetiapine
Measured: For 24 hours after dosing.
Secondary outcomes (3)
tmax of plasma concentration of unchanged quetiapine
Measured: For 24 hours after dosing.
t1/2 of plasma concentration of unchanged quetiapine
Measured: For 24 hours after dosing.
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder PatientsStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903200
- Sponsor's protocol ID
- 6949-CL-0002
- Status last verified
- Feb 2017
- First submitted
- 17 Jul 2013
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01903200
- Acronym / sponsor ID
- 6949-CL-0002
- Conditions
- Major Depressive Disorder Patients
- Keywords
- Antipsychotic, FK949E, Quetiapine, Elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jul 2013 (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.
The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FK949E Fed Group | Experimental | Drug: FK949EFK949E is administered after breakfast |
| FK949E Fasted Group | Experimental | Drug: FK949EFK949E is administered in the morning under fasting conditions |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Diagnosis of major depressive disorder according to the DSM-IV-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders version-4) criteria for any of the following:
- Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study
- Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator
Key exclusion criteria (22 listed)
- A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to the study
- Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status
- A history of substance or alcohol abuse or dependence excluding caffeine and nicotine
- Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to the start of study drug administration and throughout the study period
- Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier)
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 |
|---|---|---|
| FK949EAlso: extended release formulation of quetiapineOral | Drug | FK949E Fasted Group, FK949E Fed Group |
Primary outcome
Maximum plasma concentration (Cmax) of unchanged quetiapine
Time frame: For 24 hours after dosing.
AUC (area under the curve) of unchanged quetiapine
Time frame: For 24 hours after dosing.
3 secondary outcomes
tmax of plasma concentration of unchanged quetiapine
Time frame: For 24 hours after dosing.
t1/2 of plasma concentration of unchanged quetiapine
Time frame: For 24 hours after dosing.
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
Time frame: Up to 25 days
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 16 Feb 2017.
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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.
Medical Director study director
Astellas Pharma Inc
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 FK949E in people with Major Depressive Disorder Patients, run by Astellas Pharma Inc at 2 sites in Japan.
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 5 inclusion and 22 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 Feb 2017. 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 Japan. 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?
Maximum plasma concentration (Cmax) of unchanged quetiapine (time frame: For 24 hours after dosing.). 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 16 Feb 2017.