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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...

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Related Experiment Video

Updated: Jul 2, 2026

Clinical Efficacy of an Innovative Multidimensional Traction Therapy in Moderate Adolescent Idiopathic Scoliosis
07:12

Clinical Efficacy of an Innovative Multidimensional Traction Therapy in Moderate Adolescent Idiopathic Scoliosis

Published on: February 10, 2026

The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation.

Robert L Findling1, Jean A Frazier, Vivian Kafantaris

  • 1Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA. robert.findling@uhhospitals.org

Child and Adolescent Psychiatry and Mental Health
|August 14, 2008
PubMed
Summary
This summary is machine-generated.

This study investigates lithium treatment for pediatric bipolar disorder, establishing evidence-based dosing, efficacy, and safety. The Collaborative Lithium Trials (CoLT) provide crucial data for informed clinical decisions in youth.

Related Experiment Videos

Last Updated: Jul 2, 2026

Clinical Efficacy of an Innovative Multidimensional Traction Therapy in Moderate Adolescent Idiopathic Scoliosis
07:12

Clinical Efficacy of an Innovative Multidimensional Traction Therapy in Moderate Adolescent Idiopathic Scoliosis

Published on: February 10, 2026

Area of Science:

  • Child and Adolescent Psychiatry
  • Pharmacology
  • Clinical Trials

Background:

  • Lithium is a standard adult treatment for bipolar illness.
  • Limited rigorous research exists on lithium use in pediatric bipolarity.
  • Pediatric Bipolar Disorder (PBD) requires evidence-based treatment guidelines.

Purpose of the Study:

  • To establish evidence-based dosing strategies for lithium in pediatric patients.
  • To characterize the pharmacokinetics and biodisposition of lithium in youth.
  • To examine the acute efficacy, long-term effectiveness, and safety of lithium in pediatric bipolar disorder.

Main Methods:

  • Two multi-phase trials were designed under the Best Pharmaceuticals for Children Act (BPCA).
  • Study protocols include pharmacokinetic, efficacy, long-term effectiveness, and safety assessments.
  • Enrollment began in December 2006 across seven clinical sites.

Main Results:

  • Protocols were developed to gather comprehensive data on lithium in pediatric mania.
  • Two distinct trial structures were implemented to enhance feasibility and data acquisition.
  • Data collection focuses on dosing, pharmacokinetics, efficacy, effectiveness, and safety.

Conclusions:

  • Innovative studies will inform lithium labeling for pediatric bipolar disorder.
  • Findings will enhance clinical decision-making for treating bipolar illness in children and adolescents.
  • This research addresses a critical gap in evidence-based pediatric psychiatric care.