Phase 3
Completed N=200
A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing
Source: ClinicalTrials.gov NCT01808651 ↗Enrolled (actual)
200
Serious AEs
1.1%
Results posted
Nov 2015
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) — 2; 1; 0; 75 participants
Summary
This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants.
Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) |
2; 1; 0; 75; 46; 29 | — |
| PRIMARY Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) |
8; 4; 0 | — |
| SECONDARY Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score |
-10.04; -11.25; -11.70 | — |
| SECONDARY Percentage of Participants Achieving a Response at Week 52 |
68; 65; 83 | — |
| SECONDARY Percentage of Participants Achieving a Remission at Week 52 |
64; 57; 76 | — |
| SECONDARY Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale |
-1.41; -1.45; -1.64 | — |
| SECONDARY Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores |
-9.06; -10.20; -10.51; -4.73; -5.55; -5.02 | — |
| SECONDARY Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores |
-6.53; -6.17; -6.14; -2.46; -2.62; -2.24 | — |
Eligibility Criteria
Inclusion Criteria
- Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)
- Agree to abstain from sexual activity or to use a reliable method of birth control
Exclusion Criteria
- Significant suicidal risk
- Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
- Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
- Need to use thioridazine or pimozide during the study
- Have a positive urine drug screen for drugs with abuse potential
- Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
- Have frequent or severe allergic reactions to multiple medications
- Have a serious or unstable medical illness or condition, or psychological condition
- Participants deemed ineligible by the investigator or sub-investigator for other reasons
Data sourced from ClinicalTrials.gov (NCT01808651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.