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Duloxetine

Manufactured by Eli Lilly
Sourced in United States

Duloxetine is a pharmaceutical compound developed and manufactured by Eli Lilly. It is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used in the treatment of various medical conditions. The core function of duloxetine is to regulate the levels of neurotransmitters in the brain, which can have therapeutic effects on conditions such as depression, anxiety, and certain types of chronic pain.

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4 protocols using duloxetine

1

Antidepressant Effects in Mice Model

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Mice received 21 days of four different types of antidepressants as described previously (Sakata et al. 2013b (link)). Briefly, mice received a single intraperitoneal (i.p.) injection per day with saline or with one of the four different classes of antidepressant: fluoxetine (10 mg/kg, Mallinckrodt, Inc., Hazelwood, MO), phenelzine (10 mg/kg, Sigma, St. Louis, MO), duloxetine (20 mg/kg, Eli Lilly, Indianapolis, IN), and imipramine (10 mg/kg, Sigma). Animals were sacrificed 3 h after the last injection. The method of drug administration (i.p.), the dosage, and the sacrifice timing were decided based on previous studies (Dwivedi et al. 2006 (link), Khundakar & Zetterstrom 2006 (link), Molteni et al. 2009 (link), Mannari et al. 2008 (link), Tsankova et al. 2006 (link), Nibuya et al. 1995 (link)).
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2

Individual Patient Data Analysis of SSRI/SNRI Trials for Anxiety Disorders

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We requested IPD from Clinical Study Data Request (CSDR, https://clinicalstudydatarequest.com). We first identified all selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) developed by participating sponsors. These were paroxetine (GlaxoSmithKline), fluoxetine (Lilly), and duloxetine (Lilly). Although other SSRIs and SNRIs are also used for anxiety disorders, these were not available through CSDR. We then identified all double‐blind, placebo‐controlled, and short‐term (≤16 weeks) randomized controlled trials (RCTs) of these antidepressants for an anxiety disorder, OCD, or PTSD in adults that were mentioned in Food and Drug Administration (FDA) drug approval packages (Roest et al., 2015) or the GlaxoSmithKline (https://www.gsk-clinicalstudyregister.com) and Lilly (https://www.lilly.com/clinical-study-report-csr-synopses) trial registries.
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3

Placebo-Controlled Trials for Major Depression

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Patient-level data from 28 industry-sponsored, placebo-controlled, acute phase trials for adults with major depression using the HDRS-17 as symptom inventory were obtained for citalopram (Lundbeck, Valby, Denmark), paroxetine (GlaxoSmithKline, Brentford, UK) and sertraline (Pfizer, New York, NY, USA). In two of the paroxetine studies and one sertraline study, fluoxetine was used as active control; while these patients were also included, those treated with non-SSRI comparators were not. To corroborate results obtained using data from the SSRI trials, we also analysed patient-level data from 13 trials comparing duloxetine to placebo (Lilly, Indianapolis, IN, USA). SSRI comparators (escitalopram, fluoxetine and paroxetine) were excluded. Both these data sets have been previously described in greater detail [7 , 8 (link)].
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4

Prognostic Modeling for MDD Treatments

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We then tested the prognostic capabilities of our model using datasets from independent cohorts of MDD patients as described:

Paroxetine, fluoxetine, sertraline (248 ISPC outpatients), or escitalopram (216 outpatients from a pooled dataset obtained from Eli Lilly and Co.);

Duloxetine (1067 outpatients from pooled datasets from Eli Lilly and Co.); and

Combination pharmacotherapy with an SSRI or SNRI plus a TCA (465 hospitalized participants in the Munich Antidepressant Response Signature [MARS [21 (link)]] Study).

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