Clinical Trial for Treatment-Resistant Depression

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SEATTLE, Wash. (Ivanhoe Newswire) — More than 16 million Americans suffered at least one major episode of depression just in the last year, according to the Anxiety and Depression Association of America. Medications aren’t always effective; in fact, 30 percent of patients don’t respond. Doctors across the country are now testing a drug combination for patients with drug-resistant depression.

Laura Miller has suffered from depression since she was in her twenties. She’s tried ten medications, but nothing has worked.

“You don’t want to get out of bed; you really don’t want to do anything at all,” Miller told Ivanhoe.

Doctor Arifulla Khan hopes he is on to something to help people with treatment-resistant depression. AXS-05 is a combination of dextromethorphan, an ingredient in cough syrup, and bupropion, an antidepressant.

“So that medication inhibits the excretion, body breakdown of dexomethorphan, which is considered to be the potentially effective antidepressant,” Arifulla Khan, MD, Medical Director, Northwest Clinical Research Center explained. (Read Full Interview)

In theory, AXS-05 will allow the dextromethorphan to reach levels in the body that will ease depression. Doctor Khan is testing that in a phase three trial, seeing if the drug combination works better than bupropion alone.

Doctor Khan stated, “Theoretically should be effective, but that needs to be proven with data.”

Laura Miller is watching, with hope.

Miller explained, “To be able to feel normal and be able to get things done and be able to concentrate and to be able to have emotions. I couldn’t put a price on it.”

All patients in the trial will get bupropion for six weeks. Some will then be switched to AXS-05; the rest will stay on bupropion. The trial is running at 47 sites. You can get more information at www.trdstudy.com.

Contributors to this news report include: Wendy Chioji, Field Producer; Rusty Reed, Videographer; Cyndy McGrath, Supervising Producer; Gabriella Battistiol, Assistant Producer; Roque Correa, Editor.

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MEDICAL BREAKTHROUGHS

RESEARCH SUMMARY

TOPIC:            CLINICAL TRIAL FOR TREATMENT-RESISTANT DEPRESSION

REPORT:       MB #4350

BACKGROUND: Depression is a common and sometime serious medical illness that negatively affects the way a person feels, thinks and acts. It causes feelings of sadness and/or sometimes a loss of interest in the activities a person once enjoyed. It may lead to a variety of physical and emotional problems and can decrease a person’s ability to function at home or work. Symptoms can vary from mild to severe and may include change in appetite or weight, trouble sleeping or sleeping too much, loss of energy, increased fatigue, feeling worthless or guilty, and even thoughts of death or suicide. Symptoms must last at least two weeks for depression diagnosis, and it is important to rule out other medical conditions that may mimic certain symptoms of depression.

(Source: https://www.psychiatry.org/patients-families/depression/what-is-depression)

TREATMENT: Effective treatment for most people includes medications and psychotherapy. A primary care doctor or psychiatrist can prescribe medications to help relieve symptoms. Many people with depression also benefit from seeing a mental health professional such as a therapist or psychologist. Severe depression may require a hospital stay, or participating in an outpatient treatment program until symptoms have improved. Medications may include selective serotonin reuptake inhibitors including citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil, Pexeva), sertraline (Zoloft) and vilazodone (Viibryd). Or serotonin-norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), venlafaxine (Effexor XR), desvenlafaxine (Pristiq, Khedezla) and levomilnacipran (Fetzima). Atypical or tricyclic antidepressents, as well as other medications may be used or added to find the right balance, each on a case by case basis.

(Source: https://www.mayoclinic.org/diseases-conditions/depression/diagnosis-treatment/drc-20356013)

NEW TECHNOLOGY: AXS-05 is an investigational drug product in development. It is a combination of dextromethorphan; an ingredient in cough syrup, and bupropion; an antidepressant. In theory, AXS-05 will allow dextromethorphan to reach levels in the body that will help ease depression. It is currently in testing in a Phase Three clinical trial to see if this drug combination works better than bupropion alone. This could help patients with treatment-resistant depression who have failed two or more antidepressant therapies.

(Source: http://axsome.com/axs-05/treatment-resistant-depression-trd/

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:

Scott Stachowiak

(646) 942-5630

Scott.Stachowiak@russopartnersllc.com

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

Doctor Q and A

Read the entire Doctor Q&A for Arifulla Khan, MD

Read the entire Q&A