Abstract

The objective of this study is to evaluate the safety and efficacy of Lu 26-054 and citalopram in the treatment of panic disorder with or without agoraphobia. The clinical trial will be conducted as a randomized, double-blind, placebo-controlled, multicenter, parallel, flexible dose study. The study consists of a two-week single-blind placebo lead-in period, followed by a ten-week double-blind treatment period. Approximately 120 patients will be randomized to each double-blind treatment group (Lu 26-054, citalopram, and placebo), for a total of approximately 360 patients. Patients who meet eligibility criteria at the screening visit will enter a two-week single-blind placebo lead-in period. Patients who complete the placebo lead-in and continue to meet all entry criteria will be randomized to ten weeks of double-blind treatment with placebo, Lu 26-054, or citalopram. After the baseline visit at the end of the placebo lead-in, study visits will be conducted after 1,2,4,6,8, and 10 weeks of double-blind treatment. Patients who have missed two consecutive scheduled visits will be discontinued from the study and administered safety evaluations only.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-40
Application #
6566919
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2002
Total Cost
Indirect Cost

  Institution

Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Tita, Alan T N; Lai, Yinglei; Landon, Mark B et al. (2017) Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol 34:1464-1469
Grams, Morgan E; Yang, Wei; Rebholz, Casey M et al. (2017) Risks of Adverse Events in Advanced CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 70:337-346
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
DiMarco, Anthony F; Geertman, Robert T; Tabbaa, Kutaiba et al. (2017) Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough. Top Spinal Cord Inj Rehabil 23:271-278

Showing the most recent 10 out of 753 publications