NCT00099229CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks
Novartis Pharmaceuticals23 sites in 4 countries320 target enrollmentStarted: November 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 320
- Locations
- 23
- Primary Endpoint
- Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Study Overview
Brief Summary
This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
- •In need of psychiatric treatment
- •Cooperation and willingness to complete all aspects of the study
Exclusion Criteria
- •Current diagnosis other than bipolar I disorder
- •History of schizophrenia or schizoaffective disorder
- •Drug dependence within 1 month prior to study start or testing positive in a urine drug test
- •Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
- •Any form of psychotherapy within 1 month prior to study start
Outcomes
Primary Outcomes
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Secondary Outcomes
- Major improvement in anxiety and depression from baseline to endpoint (Week 3)
Investigators
Study Sites (23)
Loading locations...
Similar Trials
Completed
Phase 4
Antiepileptic Drug Carbamazepine in Treatment of Bronchial AsthmaBronchial AsthmaNCT00207428Centre of Chinese Medicine, Georgia65
Completed
Phase 3
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With SchizophreniaSchizophreniaNCT01412060Forest Laboratories765
Completed
Phase 3
Safety and Efficacy of Cariprazine for Bipolar I DisorderManiaBipolar I DisorderNCT01058668Forest Laboratories497
Completed
Phase 3
Safety and Efficacy of Cariprazine for ManiaManiaBipolar DisorderNCT01058096Forest Laboratories323
Completed
Phase 3
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants AloneMajor Depressive DisorderNCT03739203AbbVie752