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Depression Drug Fails in First Phase 3 Trial

Neuron illustration (NIH)

(National Institute on Aging, NIH)

A drug candidate designed to treat major depressive disorder has not met its success targets in the first round of phase 3 clinical trials. The drug, TC-5214 (S-mecamylamine), is made by global pharmaceutical company AstraZeneca and Targacept Inc., biotechnology company in Winston-Salem, North Carolina.

The clinical trial tested TC-5214 as a therapy for major depressive disorder in patients who had not responded adequately to earlier treatments for depression. The study, according to AstraZeneca, did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo.

TC-5214 addresses the overstimulation of neuronal nicotinic receptors and other receptors in the brain that are activated by the neurotransmitter acetylcholine. The drug is a nicotinic channel modulator believed to help normalize the overstimulated receptors, resulting in antidepressant effects.

Nicotinic receptors are located at synapses between two neurons and at synapses between neurons and skeletal muscle cells. When activated, a nicotinic receptor acts as a channel for the movement of ions into and out of the neuron, resulting in depolarization of the neuron.

The entire clinical trial series consists of four randomized, double blind, placebo controlled phase 3 efficacy and tolerability studies and a fifth long-term safety study. The results announced today are from a flexible dose trial conducted in Europe. AstraZeneca says, all of the phase 3 studies have completed enrollment, and reporting of results is expected by the first half of 2012.

Read more: Institutions, Companies Form Psychiatric Trial Database

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2 comments to Depression Drug Fails in First Phase 3 Trial

  • I believe my boyfriend must be suffering from moderate depression, he also gets anxiety attacks. He’s been mentioning he feels empty and low. He’s become extremely irritable, likely to blow up and argue with me over the most trivial of matters. He’s become verbally and emotionally abusive towards me, blaming me for everything that does not go smoothly. Our arguments escalate so quickly now and he gets into a rage and breaks valuables. Then he will blame his irrational behavior solely on me and convince me that I have caused his depression and rage. Sometimes he can act normal and cheery for days, then will blow up if anything at all triggers his irritability. It breaks my heart to see how this has come to be, he is no longer the same person I fell in love with. We have gone through this happy, sad, rage, promises, broken promises cycle for 2 years now. I have now checked myself into a hotel as he kicked me out of our home (technically his home since the loan is under his name, so he likes to make that known by making me unwelcome). He has agreed to seek therapy with me every time it spirals out of control, then proceeds to take it back when it’s time to go. I can’t be the glue anymore, I’m falling apart myself and he has not been my solid support for as long as I can remember. I am so heartbroken, but my only choice is to move on as he refuses to seek professional help.

  • I’m not sure how to respond, since this is a news blog and not one dispensing advice. If your friend will not voluntarily seek professional help, and you feel yourself in danger, then you — or your friend’s family — will need to take legal steps. Good luck. – Alan