Lamotrigine in Treatment Resistant Depression in Adolescents

NCT00284791 | Terminated

• 1 other identifier: MMC-2571
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 (Zoloft). Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of fluoxetine for treatment-resistant depression in adolescents. Our Secondary Aims are to characterize the factors associated with treatment-resistance for adolescents with major depression. Also to assess the relationships in the families of adolescents with major depression as they enter treatment, and to track the differences in family relationships for adolescents who respond or do not respond. We postulate that tense, frustrated, irritable, and over-involved relationships constitute a risk factor for attenuated improvement or relapse.

Conditions

Adolescent Depression

Interventions

Lamotrigine (drug) DRUG

Fluoxetine (drug) DRUG

sertraline (drug) DRUG

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Maine Medical Center Outpatient Psychiatry

Portland, Maine, 04102, United States

Location

MeSH Terms

Interventions

Lamotrigine; Pharmaceutical Preparations; Fluoxetine; Sertraline

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Douglas R Robbins, MD

  Maine Medical Center Psychiatry Department

  PRINCIPAL INVESTIGATOR

• William McFarlane, MD

  Maine Medical Center, Center for Psychiatric Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: February 1, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

US (1)