| Rank |
Status |
Study |
| 1 |
Recruiting
|
The Cymbalta Pregnancy Registry
| Condition: |
Pregnancy |
| Intervention: |
Drug: duloxetine |
| Outcome Measures: |
To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta; To estimate risk of recognized spontaneous abortions, stillbirths, elective terminations, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Cymbalta and their live births during the first year of life; To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life; To compare the risk of major congenital anomalies among pregnancies exposed to Cymbalta to an appropriate comparator(s) such as the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP) |
|
| 2 |
Unknown †
|
Cymbalta for Fibromyalgia Pain
| Condition: |
Fibromyalgia |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Nerve Histology; Improved Pain Ratings |
|
| 3 |
Recruiting
|
Crossover Trial of Duloxetine Versus Placebo in Breast Cancer Patients With Chronic Pain
| Condition: |
Pain |
| Interventions: |
Drug: Duloxetine; Drug: Placebo |
| Outcome Measures: |
Change in patient-reported pain between baseline and 6 weeks of treatment with duloxetine versus placebo; Change in objectively assessed pain sensitivity between baseline and 6 weeks of treatment with duloxetine versus placebo |
|
| 4 |
Unknown †
|
Duloxetine for Major Depression in Peri-/Postmenopausal Women
| Condition: |
Major Depressive Disorder |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).; Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).; Correlations between changes in brain activation and changes from baseline to study end and menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression (improvement and severity). |
|
| 5 |
Recruiting
|
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
| Condition: |
Chronic Low Back Pain |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10); Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10); Use of rescue medication in study phase I; Beck Depression Inventory score in phase I of study period; Health related Quality of Life SF-36 score in phase I of study period; painDetect score in phase I of study period; Use of rescue medication in phase II of study period; Beck Depression Inventory score in phase II of study period; Health related Quality of Life SF-36 score in phase II of study period.; painDetect score in phase II of study period |
|
| 6 |
Unknown †
|
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
| Condition: |
Fibromyalgia |
| Interventions: |
Drug: Duloxetine; Procedure: Skin biopsy |
| Outcome Measure: |
Efficacy of duloxetine will be determined by neurological and pain assessments. |
|
| 7 |
Unknown †
|
Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder
| Condition: |
Posttraumatic Stress Disorders |
| Intervention: |
Drug: Duloxetine hydrochloride |
| Outcome Measures: |
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS); Visual Analog Scale for Pain (VAS) |
|
| 8 |
Recruiting
|
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
| Condition: |
Total Knee Arthroplasty |
| Interventions: |
Drug: Placebo; Drug: Duloxetine 60mg |
| Outcome Measures: |
NRS Pain with ambulation at 2 weeks; Numeric Rating Scale (NRS) Pain Scores at Rest, during Ambulation and while Bending Knee |
|
| 9 |
Recruiting
|
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
| Condition: |
Back Pain Lower Back Chronic |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Number of Participants with Drug Related Adverse Events (AEs) or any Serious AE's; Change from Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50; Patient Global Impression of Improvement (PGI-Improvement) to Week 50; Change from Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50; Change from Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50; Change from Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50; Change from Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50; Change from Baseline in Beck Depression Inventory-II (BDI-II) to Week 50; Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52; Number of Participants with Fall Events from Fall Questionnaire |
|
| 10 |
Recruiting
|
Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
| Condition: |
Obsessive Compulsive Disorder |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Y-BOCS scores at 1st and last visit (17 weeks later); BDI - first and last visit (Given week 0, 1, 5, 9, 13, & 17); BAI - first and last visit (Given week 0, 1, 5, 9, 13, & 17); QLESQ - first and last visit (Given week 0 and 17); Clinical Global Impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (17 weeks post first visit) |
|
| 11 |
Recruiting
|
Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
| Conditions: |
Major Depression; Irritable Bowel Syndrome Symptoms |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Montgomery-Asberg Depression Rating Scale (MADRS); Gastrointestinal Symptoms Rating Scale (GSRS); Clinician-Rated Global Impression Scales; Visual Analogue Scales (VAS); Somatization module of the Patient's Health Questionnaire (PHQ-15) |
|
| 12 |
Recruiting
|
A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China
| Condition: |
Osteoarthritis |
| Interventions: |
Drug: Duloxetine; Drug: Placebo |
| Outcome Measures: |
Change from Baseline to 13 Weeks in the Brief Pain Inventory (BPI) 24-hour Average Pain Rating; Patient Global Impressions of Improvement (PGI-I) at 13 Weeks; Change from Baseline to 13 Weeks in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores; Change from Baseline to 13 Weeks in Clinical Global Impression of Severity (CGI-S); Change from Baseline to 13 Weeks in BPI Severity; Change from Baseline to 13 Weeks in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores |
|
| 13 |
Recruiting
|
A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
| Condition: |
Fibromyalgia |
| Interventions: |
Drug: Duloxetine; Drug: Placebo |
| Outcome Measures: |
Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item; Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference items; Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item; Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks; Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores; Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score; Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale; Change from baseline in Children's Depression Inventory (CDI); Change from baseline in Multidimensional Anxiety Scale for Children (MASC) |
|
| 14 |
Recruiting
|
Duloxetine Versus Pregabalin for Alcohol Dependence
| Condition: |
Alcohol Dependence |
| Interventions: |
Drug: Pregabalin; Drug: Duloxetine; Behavioral: Standardized behavioral therapy; Drug: Placebo |
| Outcome Measure: |
Drinking Quantity and Frequency |
|
| 15 |
Recruiting
|
Duloxetine for the Treatment of Chronic Pelvic Pain
| Condition: |
Pelvis Pain Chronic |
| Interventions: |
Drug: Duloxetine; Drug: Sugar Pill |
| Outcome Measures: |
The primary clinical efficacy measure is reduction in spontaneous (non-evoked) pelvic pain. This will be assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment.; Functional limitations due to pain |
|
| 16 |
Unknown †
|
Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
| Conditions: |
Diabetes; Painful Neuropathy |
| Intervention: |
Drug: Duloxetine |
| Outcome Measures: |
Prediction of duloxetine pain relief efficacy by pre-treatment extent of the CPM response; Treatment-related increase in CPM response |
|
| 17 |
Unknown †
|
Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
| Condition: |
Posttraumatic Stress Disorder |
| Intervention: |
Drug: Duloxetine |
| Outcome Measure: |
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD |
|
| 18 |
Not yet recruiting
|
Research Examining Gulf War Illness in Our Nations Service Members
| Condition: |
Gulf War Illness |
| Interventions: |
Drug: Duloxetine; Drug: Pregabalin; Drug: Placebo |
| Outcome Measures: |
Pain , Safety, tolerability; Side Effects |
|
| 19 |
Not yet recruiting
|
Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder
| Condition: |
Major Depressive Disorder |
| Interventions: |
Drug: Duloxetine; Drug: placebo; Other: Study visits only |
| Outcome Measures: |
>= 50% improvement in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (MADRS Response); MADRS remission; Credibility and Expectancy Scale (CES) |
|
| 20 |
Recruiting
|
S1202: Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in Pts W/Early-Stage Breast Cancer Receiving Hormone Therapy
| Conditions: |
Breast Cancer; Musculoskeletal Complications; Pain |
| Interventions: |
Drug: duloxetine hydrochloride; Other: placebo |
| Outcome Measures: |
Reduction in average joint pain according to BPI-SF assessed up to 12 weeks; Reduction in worst joint pain according to the BPI-SF worst pain score assessed up to 12 weeks; Reduction in pain interference according to the BPI-SF worst pain score assessed up to 12 weeks |
|
