NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Findling R, Taylor-Zapata P, Anand R, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development. A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase, and Open Label Restabilization Period (COLT2) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development (US); 2015 Dec 1.
A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase, and Open Label Restabilization Period (COLT2) [Internet].
Show details- 16.1.
Study Information (COLT2)
- 16.1.1.
Protocol and Protocol Amendments
- 16.1.2.
Sample Case Report Forms
- 16.1.3.
Institutional Review Boards (IRBs) and Participant Consents and Information
- 16.1.4.
Description of Investigators
- 16.1.5.
CSR Signature Pages
- 16.1.6.
Batch Numbers
- 16.1.7.
Randomization Information
- 16.1.8.
Audit Certificates
- 16.1.9.
Statistical Analysis Plan
- 16.1.10.
Documentation of Inter-laboratory Standardization Methods and Quality Assurance Procedures
- 16.1.11.
Publication Based on the Study
- 16.1.12.
Important Publications Referenced in the Report
- 16.1.13.
FDA Written Request for Lithium
- 16.2.
Participant Data Listings (COLT2)
- 16.3.
Case Report Forms for Participants with SAEs/Stopped Study Meds Due to AE (COLT2)
- 16.4.
Miscellaneous
- 16.4.1.
COLT2 Interim Analyses
- 16.4.2.
COLT1 Discontinuation Phase Unblinding Information
- 16.4.2.1.
COLT1 Treatments Assignments (Unblinded) and MedDRA Updates for AEs (datasets and define.pdf)
- 16.4.2.2.
COLT1 Unblinded Protocol Deviations
- 16.4.2.3.
COLT1 Randomization Errors (Unblinded)
- 16.5.
Datasets and Define.pdf (COLT2)
- 16.5.1.
Define.pdf
- 16.5.2.
Datasets
- 16.5.3.
SAS Programs for Efficacy Results
For documents listed but not available for download, please check the DASH repository at https://dash.nichd.nih.gov/study/16020
- APPENDICES - A Randomized, Double-Blind, Placebo Controlled Study of the Efficac...APPENDICES - A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase, and Open Label Restabilization Period (COLT2)
Your browsing activity is empty.
Activity recording is turned off.
See more...