Skip to main content
OpenTrials
Completed

NCT Number: NCT00652171

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine

Drug

Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.

Amide

Dietary Supplement

Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.

Primary outcomes

  1. Montgomery and Asberg Scale for Depression

    Time frame: 8 weeks

Secondary outcomes

  1. Clinical Global Impression

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Institute of Social Security of the Civil Servants of Minas Gerais

Other Gov

Registry information

Official study title

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 3, 2008
Registry last updated
Apr 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.