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Oleptro (trazodone hydrochloride)

Company: Labopharm
Approval Status: Approved February 2010
Treatment for: major depressive disorder
Areas: Psychiatry / Psychiatric

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Oleptro (trazodone hydrochloride) is an anti-depressant that acts as a dual serotonin agonist and serotonin reuptake inhibitor. Although the exact mechanism of action is unknown, trazodone appears to increase serotonin activity via three mechanisms: the activation of neuronal serotonin receptors; the inhibition at the neuronal serotonin receptors of the feedback system which regulates the action of serotonin; and the inhibition of the re-uptake of serotonin.

Oleptro is specifically indicated for the treatment of major depressive disorder in adults.

Oleptro is supplied as an extended-release tablet designed for oral administration. The recommended initial dose of Oleptro is 150 mg once daily. The dose may be increased by 75 mg/day every three days. The maximum daily dose should not exceed 375 mg.


Clinical Results

FDA Approval
The FDA approval of Oleptro extended release tablets was based on efficacy data evaluating the immediate release tablet formulation, as well as a randomized, double-blind, two-arm study comparing the efficacy and safety of Oleptro and placebo in the treatment of unipolar major depressive disorder. This multi-center, parallel-design study evaluated 412 outpatients meeting DSM-IV criteria for major depressive disorder. This study consisted of a baseline phase (screening and washout) and a double-blind randomized phase. The total study duration, including washout of prohibited medications, was approximately 11 weeks. The primary efficacy endpoint was change from baseline in HAMD-17 total score. A statistically significant difference in the HAMD-17 score was demonstrated at 8 weeks between the Oleptro group and the placebo group.


Side Effects

Adverse events associated with the use of Oleptro may include, but are not limited to, the following:

  • Somnolence
  • Sedation
  • Dizziness
  • Constipation
  • Vision blurred
  • Headache


Mechanism of Action

Oleptro (trazodone hydrochloride) is an anti-depressant that acts as a dual serotonin agonist and serotonin reuptake inhibitor. Although the exact mechanism of action is unknown, trazodone appears to increase serotonin activity via three mechanisms: the activation of neuronal serotonin receptors; the inhibition at the neuronal serotonin receptors of the feedback system which regulates the action of serotonin; and the inhibition of the re-uptake of serotonin.


Literature References

Sheehan DV, Croft HA, Gossen ER, Levitt RJ, Brullé C, Bouchard S, Rozova A Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study. Psychiatry 2009 May;6(5):20-33


Additional Information

For additional information regarding Oleptro or major depressive disorder, please visit the Oleptro web page.




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Oleptro Drug Information

The Oleptro drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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