A Study in Depression and Associated Painful Physical Symptoms
10 janvier 2012 mis à jour par: Eli Lilly and Company
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
527
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Caguas, Porto 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, Porto 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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, États-Unis, 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
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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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Expérimental: Duloxétine
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Changement par rapport à la ligne de base des scores totaux et des éléments de l'échelle d'incapacité Sheehan (SDS) à la semaine 8
Délai: Base de référence, 8 semaines
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La FDS est remplie par le participant ; utilisé pour évaluer l'effet des symptômes du participant sur sa vie professionnelle/sociale/familiale.
Les scores totaux vont de 0 à 30 ; des valeurs plus élevées indiquent une plus grande perturbation de la vie professionnelle/sociale/familiale du participant.
Le score de chaque élément varie de 0 à 10, les valeurs les plus élevées indiquant une plus grande perturbation de la vie professionnelle/scolaire du participant (élément 1), de la vie sociale/des activités de loisirs (élément 2) ou de la vie familiale/des responsabilités familiales (élément 3).
La valeur moyenne LS a été ajustée pour le traitement, l'investigateur, la visite, la ligne de base, l'interaction traitement*visite et l'interaction ligne de base*visite.
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Base de référence, 8 semaines
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Changement par rapport au départ dans les scores d'intensité et d'interférence de l'inventaire bref de la douleur (BPI-S/BPI-I) à la semaine 8
Délai: Base de référence, 8 semaines
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Mesure la sévérité de la douleur et les interférences sur la fonction.
Scores de sévérité : 0 (pas de douleur) à 10 (douleur intense) à chaque question.
Scores d'interférence : de 0 (n'interfère pas) à 10 (interfère complètement) à chaque question évaluant l'interférence de la douleur au cours des dernières 24 heures pour l'activité générale, l'humeur, la capacité de marcher, le travail normal, les relations avec les autres, le sommeil et la joie de vivre.
Interférence moyenne = moyenne des scores non manquants des éléments d'interférence individuels.
Valeur moyenne LS ajustée pour le traitement, l'investigateur, la visite, la ligne de base, l'interaction traitement*visite et l'interaction ligne de base*visite.
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Base de référence, 8 semaines
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Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changement de la fréquence de base du pouls jusqu'à la semaine 8
Délai: Baseline, jusqu'à la semaine 8
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Le changement par rapport à la ligne de base du pouls à la semaine 8 est l'analyse principale. Pour l'analyse principale du pouls, la valeur moyenne des moindres carrés (LS) a été ajustée pour le traitement, l'investigateur, la ligne de base, l'interaction traitement*visite et l'interaction ligne de base*visite. Le changement de la fréquence du pouls par rapport à la ligne de base jusqu'à la semaine 8 est l'analyse secondaire. La valeur moyenne LS a été ajustée pour le traitement, l'investigateur et la ligne de base. |
Baseline, jusqu'à la semaine 8
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Changement par rapport à la ligne de base de la pression artérielle systolique (PAS) et de la pression artérielle diastolique (PAD) jusqu'à la semaine 8
Délai: Baseline, jusqu'à la semaine 8
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Le changement par rapport à la ligne de base de la PAS et de la PAD à la semaine 8 est l'analyse principale. Pour l'analyse principale de la PAS et de la PAD, la valeur moyenne des moindres carrés (LS) a été ajustée pour le traitement, l'investigateur, la ligne de base, l'interaction traitement*visite et l'interaction ligne de base*visite. Le changement par rapport à la ligne de base de la PAS et de la PAD jusqu'à la semaine 8 est l'analyse secondaire. La valeur moyenne LS a été ajustée pour le traitement, l'investigateur et la ligne de base. |
Baseline, jusqu'à la semaine 8
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Changement du poids de base jusqu'à la semaine 8
Délai: Baseline, jusqu'à la semaine 8
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Le changement de poids par rapport au départ à la semaine 8 est l'analyse principale. Pour l'analyse principale du poids, la valeur moyenne des moindres carrés (LS) a été ajustée en fonction du traitement, de l'investigateur, de la ligne de base, de l'interaction traitement*visite et de la ligne de base*interaction visite. Le changement de poids de base jusqu'à la semaine 8 est l'analyse secondaire. La valeur moyenne LS a été ajustée pour le traitement, l'investigateur et la ligne de base. |
Baseline, jusqu'à la semaine 8
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Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2010
Achèvement primaire (Réel)
1 mars 2011
Achèvement de l'étude (Réel)
1 mars 2011
Dates d'inscription aux études
Première soumission
16 février 2010
Première soumission répondant aux critères de contrôle qualité
16 février 2010
Première publication (Estimation)
18 février 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
13 février 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 janvier 2012
Dernière vérification
1 janvier 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Troubles de l'humeur
- La dépression
- Dépression
- Trouble dépressif majeur
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Médicaments psychotropes
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents antidépresseurs
- Agents dopaminergiques
- Inhibiteurs de la recapture de la sérotonine et de la noradrénaline
- Chlorhydrate de duloxétine
Autres numéros d'identification d'étude
- 13630
- F1J-US-HMGU (Autre identifiant: Eli Lilly and Company)
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