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Also known as LY110140, Prozac, Sarafem, LY1101440
Fluoxetine · 6 trials · 3 indications
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.
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.
Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Fluoxetine | EXPERIMENTAL | Flexible dosing of 20 to 40 milligrams (mg) administered orally, once daily, for approximately 52 weeks |
| 20 mg Fluoxetine | EXPERIMENTAL | 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| 40 mg Fluoxetine | EXPERIMENTAL | 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo (capsules) administered orally, once daily, for 6 weeks |
| Olanzapine and Fluoxetine combination (OFC) | EXPERIMENTAL | - |
| Duloxetine 60 mg | EXPERIMENTAL | - |
| Duloxetine 30 mg | EXPERIMENTAL | - |
| 5 milligrams (mg) LY110140 (SD) | EXPERIMENTAL | 5 mg administered once in the fasted state on Day 1 |
| 20 mg LY110140 (SD) | EXPERIMENTAL | 20 mg administered once in the fasted state on Day 1 |
| 40 mg LY110140 (SD) | EXPERIMENTAL | 40 mg administered once in the fasted state on Day 1 |
| Placebo (MD) | PLACEBO_COMPARATOR | Placebo once daily oral dosing for 28 consecutive days |
| 20 mg LY110140 (MD) | EXPERIMENTAL | 20 mg once daily oral dosing for 28 consecutive days |
| 40 mg LY110140 (MD) | EXPERIMENTAL | 40 mg once daily oral dosing for 28 consecutive days |
| Name | Type | Description |
|---|---|---|
| Fluoxetine | DRUG | Administered orally |
| Placebo | DRUG | - |
| Olanzapine and Fluoxetine combination (OFC) | DRUG | Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks. Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks. Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks. |
| duloxetine | DRUG | 60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase) |
| Olanzapine | DRUG | - |
| LY110140 | DRUG | Administered orally as capsules |
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, schizoph...
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Fluoxetine is studied for Major Depressive Disorder and Treatment Resistant Depression. It is a small molecule developed by Eli Lilly and Company for the psychiatry therapeutic area. Four Phase 3 trials have been completed in these indications, including studies in adults, children, and adolescents.
Fluoxetine targets SLC6A4, the serotonin transporter, and acts as an inhibitor of this target. By inhibiting SLC6A4, fluoxetine affects serotonergic signaling, which is the basis for its study in Major Depressive Disorder and Treatment Resistant Depression.
Fluoxetine is developed by Eli Lilly and Company, which trades under the ticker LLY. The company has sponsored the Phase 3 clinical program evaluating fluoxetine in Major Depressive Disorder and Treatment Resistant Depression.
Fluoxetine is in Phase 3 clinical development for Major Depressive Disorder and Treatment Resistant Depression. Four Phase 3 trials have been completed, and none are currently active. The program includes randomized, double-blind, placebo-controlled studies.
Completed Phase 3 trials of fluoxetine include NCT01808651 and NCT01808612 in Major Depressive Disorder in Japan, NCT00958568 in Treatment Resistant Depression across multiple countries, and NCT00849693 in children and adolescents with Major Depressive Disorder. Total enrollment across these four trials was 1,776 participants.
Fluoxetine is also known by the brand name Prozac. Both names refer to the same small molecule developed by Eli Lilly and Company, studied in Phase 3 trials for Major Depressive Disorder and Treatment Resistant Depression.