We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652171
First Posted: April 3, 2008
Last Update Posted: April 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Social Security of the Civil Servants of Minas Gerais
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: April 1, 2008
First Posted: April 3, 2008
Last Update Posted: April 9, 2008
Last Verified: April 2008

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
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Lamotrigine
Anticonvulsants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers


To Top