Trial | NCT00652171  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lamotrigine ...

  • Study Participants

    34
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.
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.
Study Started
Jan 31
2004
Primary Completion
Jan 31
2006
Study Completion
Jan 31
2006
Last Update
Apr 09
2008
Estimate

Drug Lamotrigine

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

Dietary Supplement Amide

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

1 Active Comparator

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.

2 Placebo Comparator

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

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
No Results Posted