Oral Multiple-dose Study in Patients With Major Depressive Disorder

NCT01924520 | Completed Phase 1

• 1 other identifier: 6949-CL-0009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

Antipsychotic; FK949E; Quetiapine

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of unchanged quetiapine

  for 24 hours after dosing

• AUC24h (area under the curve for 24hr) of unchanged quetiapine

  for 24 hours after dosing

Secondary Outcomes (8)

• trough value of plasma concentration of unchanged quetiapine

  for 24 hours after dosing

• t1/2 of plasma concentration of unchanged quetiapine

  for 24 hours after dosing

• Maximum plasma concentration (Cmax) of quetiapine metabolites

  for 24 hours after dosing

• AUC (area under the curve) of quetiapine metabolites

  for 24 hours after dosing

• trough value of plasma concentration of quetiapine metabolites

  for 24 hours after dosing

Study Arms (3)

Group 1 (FK949E lower dose)

EXPERIMENTAL

Oral

Drug: FK949E

Group 2 (FK949E middle dose)

EXPERIMENTAL

Oral

Drug: FK949E

Group 3 (FK949E higher dose)

EXPERIMENTAL

Oral

Drug: FK949E

Interventions

FK949E DRUG

Oral

Also known as: extended-release formulation of quetiapine

Group 1 (FK949E lower dose); Group 2 (FK949E middle dose); Group 3 (FK949E higher dose)

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR
• 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.

You may not qualify if:

• A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to provision of written informed consent.
• 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 screening assessment 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 being treated for hypertension or patients with 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).
• Patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmHg)
• 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 history 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 screening assessment and throughout the study period
• A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months. Patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 16, 2013
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

JP (2)