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Major Depressive Disorder PatientsPhase 1NCT01871974

Study to Evaluate Safety and Tolerability of FK949E in 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 patients with major depressive disorder (MDD). Read more about this study

Who is it for?
Ages 20 to 64 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
May 2009to Mar 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 20 to 64 years
  • All sexes
  • No healthy volunteers
  • 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)
  • 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
  • Pregnant or lactating women
  • 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)
Show all 21Show fewer
  • A clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina)
  • Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)
  • A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma)
  • A current or past diagnosis of transient ischemic attack (TIA)
  • A history of seizure disorder, except for febrile convulsions
  • Application 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 could require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy had been ongoing for a minimum of 90 days prior to the start of 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.

Japan2 sites

  • Study site

    Kansai

  • Study site

    Kantou

Other trials in Japan

About this study

Official title: Phase I Study of FK949E - Multiple Dose Study of Non-Elderly Adult Patients With Major Depressive Disorder (MDD)

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 patients with major depressive disorder (MDD).

Read the detailed description

This is a dose-titration study. In low-dose-group, patients receive prescribed dose on Day 5 after 3-step dose increases. In high-dose-group patients receive prescribed dose on Day 7 after 4-step dose increases. Patients receive prescribed dose of FK949E for 7 days in each group. The dosage period is 12 days in low dose group and 14 days in high dose group.

Being tested
FK949E
Keywords
FK949E, Antipsychotic, Quetiapine

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 groups in NCT01871974
Study groupRoleWhat they receive
low-dose group FK949EExperimentaloral
Receives: Drug: FK949E
high-dose group FK949EExperimentaloral
Receives: Drug: FK949E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum plasma concentration (Cmax) of unchanged quetiapine

    Measured: For 24 hours after dosing

Secondary outcomes (4)

  1. AUC (area under the curve) of unchanged quetiapine

    Measured: For 24 hours after dosing

  2. tmax of plasma concentration of unchanged quetiapine

    Measured: For 24 hours after dosing

  3. t1/2 of plasma concentration of unchanged quetiapine

    Measured: For 24 hours after dosing

  4. Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam

    Measured: Up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871974
Sponsor's protocol ID
6949-CL-0001
Status last verified
Feb 2017
First submitted
5 Jun 2013
Last updated
16 Feb 2017
Results posted
No
Data monitoring committee
No

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 3 inclusion and 21 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871974.

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.

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