A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing

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• Depressive Disorder, Major 2,805

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Study arms

• Experimental
  Fluoxetine

  Flexible dosing of 20 to 40 milligrams (mg) administered orally, once daily, for approximately 52 weeks

  Drug: Fluoxetine

Interventions

• DrugFluoxetine

  Administered orally

  Also known as: LY110140, Fluoxetine Hydrochloride, Prozac, Sarafem

Primary outcomes

1. Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)

   Time frame: Baseline through Week 52.

2. Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)

   C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

   Time frame: Baseline through Week 52

Secondary outcomes

1. Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score

   HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.

   Time frame: Baseline, Week 52

2. Percentage of Participants Achieving a Response at Week 52

   The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.

   Time frame: Baseline, up to Week 52

3. Percentage of Participants Achieving a Remission at Week 52

   The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.

   Time frame: up to Week 52

4. Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale

   CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.

   Time frame: Baseline, Week 52

5. Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores

   HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.

   Time frame: Baseline, Week 52

6. Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores

   SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.

   Time frame: Baseline up to 52 weeks

Baseline characteristics