Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Phase 3TerminatedNCT01131559

Lindner Center of HOPE50 enrolled

Overview

The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bipolar Depression

Interventions

LisdexamfetamineDRUG

Oral; 20-70mg/day

Placebo controlDRUG

Oral; 20-70mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will meet DSM-IV-TR criteria bipolar I or II disorder, Exclusion Criteria: * Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. * Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Locations (1)

Lindner Center of HOPE

Mason, Ohio, United States

Outcomes

Primary Outcomes

Change in MADRS score

The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.

Time frame: 30-36 months

Data from ClinicalTrials.gov

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