Status:
TERMINATED
Lamotrigine in Treatment Resistant Depression in Adolescents
Lead Sponsor:
MaineHealth
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Adolescent Depression
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as effective as sertraline ...
Detailed Description
Mood disorders in youth, which include Major Depressive Disorder (MDD) and Bipolar Disorder (BPD), are highly prevalent, and are associated with significant mortality and morbidity. Many youths with m...
Eligibility Criteria
Inclusion
- Adolescents (13-17) diagnosed with a major depressive episode (MDE) (DSM-IV criteria) from either major depressive disorder (MDD) or bipolar disorder (BPD). BPD can present as a major depressive episode, with previous or subsequent cycling into a hypomanic, manic, or mixed episode. By definition, major depressive disorder MDD requires the presence of a major depressive episode, without cycling into a hypomanic, manic, or mixed episode.
- CDRS (Children's Depression Rating Scale) \> 40.
- CGAS (Children's Global Assessment Scale) \< 60.
Exclusion
- Adolescents who meet the following criteria will be excluded from the study:
- Prior medically serious suicide attempt, within 3 months of enrollment into study or a score of 3 on suicide questions within KSADS at initial visit or the side effect checklist on follow up visits regarding current state.
- Known or suspected mental retardation. For patients with known mental retardation, full scale IQ below 70 should be documented.
- Current significant physical illnesses (e.g. diabetes mellitus, asthma, cystic fibrosis, congenital heart defects, genetic disorders). Patients with seizure disorders taking anticonvulsants will be excluded (no concomitant anticonvulsants).
- Current drug or alcohol abuse. No active abuse will be permitted within two weeks of beginning the study trial (confirmed by urine testing in all cases of suspected abuse).
- Females who are sexually active and are unwilling or considered unable to use appropriate contraception.
- Use of benzodiazepines and other anxiolytics, antipsychotic medications, other antidepressants, stimulant medication, other mood stabilizers (e.g., lithium, valproate), and other sedative-hypnotics will not be permitted
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00284791
Start Date
January 1 2006
End Date
February 1 2007
Last Update
May 17 2017
Active Locations (1)
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1
Maine Medical Center Outpatient Psychiatry
Portland, Maine, United States, 04102