Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

This study has been completed.
Sponsor:
Information provided by:
Institute of Social Security of the Civil Servants of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00652171
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008
  Purpose

This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.


Condition Intervention Phase
Depression
Drug: Lamotrigine
Dietary Supplement: Amide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression

Resource links provided by NLM:


Further study details as provided by Institute of Social Security of the Civil Servants of Minas Gerais:

Primary Outcome Measures:
  • Montgomery and Asberg Scale for Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: January 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
17 Patients - Mean age of 26 years old, 14 female and 3 male - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.
Drug: Lamotrigine
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
Placebo Comparator: 2
17 Patients - 11 females and 6 males mean age of 29 years old - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.
Dietary Supplement: Amide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.

Detailed Description:

Objective: This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.

Method: A double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients who had DSM-IV major depressive disorder and were resistant to at least 2 antidepressants. The subjects were on taking antidepressant therapy and were randomly assigned to receive placebo or lamotrigine as an adjunct therapy for 8 weeks. They were evaluated on a biweekly basis in order to access assess the efficacy and the safety of the drug.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • They were selected according to a clinical interview based on DSM-IV criteria for major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides
  • They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11

    • failure to respond to treatment with at least 2 antidepressants of different classes
    • at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms

Exclusion Criteria:

  • Pregnant or lactating women or those capable of getting pregnant that who were not using contraceptive methods were excluded as well as patients with severe clinical diseases or organic mental disorder
  • Further exclusion criteria were acute depression with risk of suicide
  • psychosis
  • and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652171

Sponsors and Collaborators
Institute of Social Security of the Civil Servants of Minas Gerais
Investigators
Principal Investigator: Milena A Santos, Master City Hall of Beló Horizonte
Study Chair: Claudia Hara, Master Faculdade de Saúde e Ecologia Humana
Study Director: Fabio L Rocha, PhD Institute of Social Security of the Civil Servants of Minas Gerais
  More Information

Additional Information:
Publications:
Responsible Party: Milena Antunes Santos/Dr, Post - Graduation in Health Sciences, IPSEMG
ClinicalTrials.gov Identifier: NCT00652171     History of Changes
Other Study ID Numbers: CEP: 093/03
Study First Received: April 1, 2008
Last Updated: April 3, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Institute of Social Security of the Civil Servants of Minas Gerais:
Treatment
Augmentation
Resistant depression
Lamotrigine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Lamotrigine
Anticonvulsants
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 19, 2014