Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Institute of Social Security of the Civil Servants of Minas Gerais

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Dietary Supplement: Amide; Drug: Lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT00652171

CEP: 093/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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.

Treatment:

Drug: Lamotrigine

2

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Amide