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Early Trial Shows Neural Regrowth Effects on Depression

3-D brain wiring illustration

3-D brain wiring illustration (NIH)

25 June 2014. An early-stage clinical trial by Neuralstem Inc. in Germantown, Maryland provides evidence its experimental drug to treat major depressive disorder is having a positive impact on patients’ brain activity and behavior. The company reported the findings yesterday at a meeting of the International College of Neuropsychopharmacology in Vancouver, Canada, and last week at a meeting of the American Society of Clinical Psychopharmacology in Hollywood, Florida.

Major depressive disorder is an acute form of depression that affects thought and behavior of people with the condition, interfering with daily family and work life, and often requiring clinical intervention to treat effectively. Counseling and medications are often prescribed as treatments, with selective serotonin reuptake inhibitors (e.g. Prozac, Zoloft) among the most widely prescribed.

Neuralstem develops therapies for central nervous system disorders with stem cells to produce regenerative treatments. The company uses those same stem cell lines to screen for new drug compounds to treat diseases of the brain and spinal cord, including its small-molecule oral drug candidate code-named NSI-189 that aims to improve the regenerative capacity of the hippocampus. The hippocampus is the part of the brain rich in neural stem cells that generates new neurons in the brain, and reduced hippocampus capacity is associated with depression.

The clinical trial recruited 24 patients having major depressive disorder in Glendale, California, with part of the sample receiving 1 to 3 doses a day of either NSI-189 or a placebo for 28 days. The trial assessed the safety of the drug, as well as its effects on brain activity, measured by EEG and other tests. The researchers also evaluated the patients with standard behavioral indexes, including Symptoms of Depression Questionnaire, Cognitive and Physical Functioning Questionnaire, and Columbia Suicide Severity Rating Scale.

At yesterday’s meeting of the International College of Neuropsychopharmacology, the company reported patients in the trial receiving NSI-189 had higher brain wave activity patterns in the hippocampus region of the brain than patients receiving placebos. Quantitative EEG readings from parts of the brain affecting memory and cognitive activity, say the researchers, indicate the drug contributed to long-term structural changes in the hippocampus.

At the earlier American Society of Clinical Psychopharmacology meeting, the company reported on results of the behavioral indexes. At that meeting, researchers said at day 28 patients taking NSI-189 made more improvements in their scores on the Symptoms of Depression Questionnaire than patients receiving a placebo. Patients at day 28 receiving NSI-189 also scored higher on the Cognitive and Physical Functioning Questionnaire than their counterparts taking a placebo. In addition, say the researchers, the large differences persisted 8 weeks after the drug treatments ended.

The company plans an intermediate-stage trial to begin in the first quarter of 2015 of some 150 patients at multiple sites, testing 1 or 2 doses a day of NSI-189 against a placebo.

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