Clinical Study Of Schizophrenia in Both Men and Women
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ClinicalTrials.gov Identifier: NCT00071747 |
Recruitment Status
:
Completed
First Posted
: October 31, 2003
Last Update Posted
: September 1, 2016
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | |||||
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First Submitted Date ICMJE | October 30, 2003 | ||||
First Posted Date ICMJE | October 31, 2003 | ||||
Last Update Posted Date | September 1, 2016 | ||||
Study Start Date ICMJE | August 2003 | ||||
Primary Completion Date | Not Provided | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12. [ Time Frame: 12 Weeks ] | ||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | Complete list of historical versions of study NCT00071747 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12. [ Time Frame: 12 Weeks ] | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Study Of Schizophrenia in Both Men and Women | ||||
Official Title ICMJE | A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia | ||||
Brief Summary | The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | ||||
Intervention ICMJE | Drug: lamotrigine | ||||
Study Arms | Not Provided | ||||
Publications * | Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE |
176 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date | January 2005 | ||||
Primary Completion Date | Not Provided | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00071747 | ||||
Other Study ID Numbers ICMJE | SCA30926 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||
Verification Date | August 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |