- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01070329
A Study in Depression and Associated Painful Physical Symptoms
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskelupaikat
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Caguas, Puerto Rico, 00725
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00926
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Sherman Oaks, California, Yhdysvallat, 91403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Connecticut
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Cromwell, Connecticut, Yhdysvallat, 06416
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Fort Lauderdale, Florida, Yhdysvallat, 33319
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orlando, Florida, Yhdysvallat, 32806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30308
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Hoffman Estates, Illinois, Yhdysvallat, 60194
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Illinois, Yhdysvallat, 62711
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Evansville, Indiana, Yhdysvallat, 47714
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Florence, Kentucky, Yhdysvallat, 41042
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Louisiana
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Lake Charles, Louisiana, Yhdysvallat, 70601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Belmont, Massachusetts, Yhdysvallat, 02478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Boston, Massachusetts, Yhdysvallat, 02135
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Troy, Michigan, Yhdysvallat, 48083
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Toms River, New Jersey, Yhdysvallat, 08755
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Willingboro, New Jersey, Yhdysvallat, 08046
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Brooklyn, New York, Yhdysvallat, 11235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rochester, New York, Yhdysvallat, 14618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Staten Island, New York, Yhdysvallat, 10305
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Beachwood, Ohio, Yhdysvallat, 44122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toledo, Ohio, Yhdysvallat, 43623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Portland, Oregon, Yhdysvallat, 97210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salem, Oregon, Yhdysvallat, 97301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Allentown, Pennsylvania, Yhdysvallat, 18104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Media, Pennsylvania, Yhdysvallat, 19063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Philadelphia, Pennsylvania, Yhdysvallat, 19107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rhode Island
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Lincoln, Rhode Island, Yhdysvallat, 02865
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Memphis, Tennessee, Yhdysvallat, 38119
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Wichita Falls, Texas, Yhdysvallat, 76309
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Richmond, Virginia, Yhdysvallat, 23230
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellevue, Washington, Yhdysvallat, 98007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Middleton, Wisconsin, Yhdysvallat, 53562
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Key Inclusion Criteria:
- Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
- At least 1 previous episode of depression
- Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
- A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
- Written informed consent
Key Exclusion Criteria:
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
- Women of child-bearing potential who are not using a medically accepted means of contraception
- Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
- Have any prior history of bipolar disorder, psychosis, or schizophrenia
- Have an Axis II disorder that would interfere with study compliance
- Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
- Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
- Diagnosis of acute liver injury or severe cirrhosis
- Uncontrolled narrow-angle glaucoma
- Positive urine drug screen for any substance of abuse
- Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
- History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
- Requires continuous use of analgesics for 6 or more months because of chronic pain
- Has pain of a known origin
- Meets criteria for fibromyalgia as defined by the American College of Rheumatology
- Experiences greater than or equal to 1 migraine headache per week
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
- Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
- Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
- Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days after discontinuation of study drug
- Abnormal thyroid stimulating hormone
- Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Plasebo
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Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.
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Kokeellinen: Duloksetiini
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Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks.
Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
Aikaikkuna: Day 1 through 8 weeks
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A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
The overall change is based on the estimated main treatment effect.
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Day 1 through 8 weeks
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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
Aikaikkuna: Baseline, 8 weeks
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The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 8 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Muutos lähtötasosta Sheehanin vammaisuusasteikon (SDS) kokonaispisteissä ja tuotepisteissä viikolla 8
Aikaikkuna: Perustaso, 8 viikkoa
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Osallistuja täyttää käyttöturvallisuustiedotteen; käytetään arvioimaan osallistujan oireiden vaikutusta työ-/yhteiskunnalliseen/perhe-elämään.
Kokonaispisteet vaihtelevat 0-30; korkeammat arvot osoittavat suurempaa häiriötä osallistujan työssä/sosiaalisessa/perhe-elämässä.
Jokaisen kohteen pisteet vaihtelevat 0–10, ja korkeammat arvot osoittavat suurempaa häiriötä osallistujan työ-/kouluelämässä (kohta 1), sosiaalisessa elämässä/harrastustoiminnassa (kohta 2) tai perhe-elämässä/kodin velvollisuuksissa (kohta 3).
LS-keskiarvoa säädettiin hoidon, tutkijan, käynnin, lähtötilanteen, hoito*käyntivuorovaikutuksen ja lähtötason*käyntivuorovaikutuksen perusteella.
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Perustaso, 8 viikkoa
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Muutos lähtötasosta lyhyen kivun vakavuus- ja häiriöpisteet (BPI-S/BPI-I) viikolla 8
Aikaikkuna: Perustaso, 8 viikkoa
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Mittaa kivun vaikeutta ja häiriöitä toimintaan.
Vakavuuspisteet: 0 (ei kipua) 10 (kova kipu) jokaisessa kysymyksessä.
Häiriöpisteet: 0 (ei häiritse) - 10 (häiritsee täysin) jokaisessa kysymyksessä, jossa arvioidaan kivun häiriöitä viimeisen 24 tunnin aikana yleisen aktiivisuuden, mielialan, kävelykyvyn, normaalin työn, suhteiden muihin ihmisiin, unen ja elämästä nauttimisen osalta.
Keskimääräinen häiriö = yksittäisten häiriökohteiden ei-puuttuvien pisteiden keskiarvo.
LS-keskiarvo oikaistu hoidon, tutkijan, käynnin, lähtötilanteen, hoito*käynti-vuorovaikutuksen ja lähtötason*käyntivuorovaikutuksen perusteella.
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Perustaso, 8 viikkoa
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Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
Aikaikkuna: Baseline, up to 8 weeks
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The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12.
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Baseline, up to 8 weeks
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Percentage of Participants Achieving Remission up to Week 8
Aikaikkuna: Up to 8 weeks
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The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).
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Up to 8 weeks
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
Aikaikkuna: Baseline, 4 weeks
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The MADRS is a rating scale for severity of depressive mood and symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 4 weeks
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
Aikaikkuna: Baseline, 2 weeks
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The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 2 weeks
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Patient Global Impression of Improvement (PGI-I) Score at Week 8
Aikaikkuna: 8 weeks
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A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment.
The score ranges from 1 (very much better) to 7 (very much worse).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.
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8 weeks
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Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
Aikaikkuna: Baseline through 8 weeks
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The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of participants with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal acts: a "yes" answer to actual attempt or completed suicide.
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Baseline through 8 weeks
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Muutos pulssin lähtötasosta viikkoon 8
Aikaikkuna: Perustaso, viikkoon 8 asti
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Ensisijainen analyysi on pulssin muutos lähtötasosta viikolla 8. Ensisijaista pulssin analyysiä varten pienimmän neliösumman (LS) keskiarvo säädettiin hoidon, tutkijan, lähtötilanteen, hoito*käynti-vuorovaikutuksen ja lähtötason*käyntivuorovaikutuksen mukaan. Syketiheyden muutos lähtötilanteesta viikkoon 8 asti on toissijainen analyysi. LS-keskiarvo mukautettiin hoidon, tutkijan ja lähtötilanteen mukaan. |
Perustaso, viikkoon 8 asti
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Muutos lähtötasosta systolisessa verenpaineessa (SBP) ja diastolisessa verenpaineessa (DBP) viikkoon 8 asti
Aikaikkuna: Perustaso, viikkoon 8 asti
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SBP:n ja DBP:n muutos lähtötasosta viikolla 8 on ensisijainen analyysi. SBP:n ja DBP:n ensisijaista analyysiä varten pienimmän neliösumman (LS) keskiarvoa säädettiin hoidon, tutkijan, lähtötilanteen, hoito*käyntivuorovaikutuksen ja lähtötason*käyntivuorovaikutuksen mukaan. SBP:n ja DBP:n muutos lähtötilanteesta viikkoon 8 on toissijainen analyysi. LS-keskiarvo mukautettiin hoidon, tutkijan ja lähtötilanteen mukaan. |
Perustaso, viikkoon 8 asti
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Muutos peruspainosta viikkoon 8
Aikaikkuna: Perustaso, viikkoon 8 asti
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Ensisijainen analyysi on painon muutos lähtötasosta viikolla 8. Painon ensisijaista analyysiä varten pienimmän neliösumman (LS) keskiarvoa säädettiin hoidon, tutkijan, lähtötilanteen, hoito*käyntivuorovaikutuksen ja lähtötason*käyntivuorovaikutuksen mukaan. Painon muutos lähtötilanteesta viikkoon 8 asti on toissijainen analyysi. LS-keskiarvo mukautettiin hoidon, tutkijan ja lähtötilanteen mukaan. |
Perustaso, viikkoon 8 asti
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Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine
Aikaikkuna: Baseline through 8 weeks
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Laboratory assessment of creatinine during the double-blind treatment phase.
Normal creatinine ranges for males are 40.00
micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high).
Normal creatinine ranges for females are 31.00
µmol/L (low) to 101.00 µmol/L (high).
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Baseline through 8 weeks
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
- Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Käyttäytymisoireet
- Mielenterveyshäiriöt
- Mielialahäiriöt
- Masennus
- Masennushäiriö
- Masennus, majuri
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Ääreishermoston aineet
- Analgeetit
- Aistijärjestelmän agentit
- Psykotrooppiset lääkkeet
- Neurotransmitterien sisäänoton estäjät
- Kalvon kuljetusmodulaattorit
- Masennuslääkkeet
- Dopamiini-aineet
- Serotoniinin ja noradrenaliinin takaisinoton estäjät
- Duloksetiinihydrokloridi
Muut tutkimustunnusnumerot
- 13630
- F1J-US-HMGU (Muu tunniste: Eli Lilly and Company)
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