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Venlafaxine Extended-Release Might Be Effective for Depressed Adolescents But Should be Prescribed With Attention to Risks: Presented at AACAP

By Jerry Ingram

WASHINGTON, DC -- October 28, 2004 -- Venlafaxine extended release (Effexor) may be another option for treatment of adolescents suffering with major depressive disorder (MDD), but physicians should be alert to any signs of suicidal thoughts and hostility in patients receiving this agent, according to two 8-week, multicenter, double-blind, randomized study.

Lead investigator Graham Emslie, MD, Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, and his associates presented the findings here on October 21st at the 51st Annual Meeting of the American Academy of Child and Adolescent Psychiatry.

There is currently little data available on the use of venlafaxine extended release (ER) for treatment of pediatric patients with MDD. Dr. Emslie and colleagues therefore combined data from two flexible-dose, double-blind studies that used the Children's Depression Rating Scale-Revised total score to measure primary treatment efficacy. Investigators based the primary end point on the final on-therapy evaluation.

The studies enrolled 137 children (ages 6 to 11 years) and 197 adolescents (ages 12 to 17 years); 169 patients were randomized to venlafaxine (XR) with dose set according to weight and 165 patients received placebo.

Dr. Emslie and his team found that children taking venlafaxine (XR) experienced an adjusted mean decrease of 22.7 points on the primary efficacy variable compared to a 24.0 decrease for the placebo group (P =.053). In the adolescents who received venlafaxine there was an adjusted mean decrease of 24.4 points on the primary efficacy variable versus a 19.9 decrease for the placebo group (P =.022).

The investigators cautioned that hostility and suicide-related adverse events occurred more often in the venlafaxine group than in the placebo group.

Although venlafaxine XR might be effective for treatment of depressed adolescents, they urge clinicians to be alert to signs of suicidal ideation and/or hostility in children and teens treated with this medication, they concluded.


[Presentation title: "Venlafaxine XR in Pediatric Patients with Major Depressive Disorder." Poster B32]

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