Navigation Links
Targacept's P.2b depression study succeeds: 6-point difference on HAM-D
Date:10/16/2009

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide. In the trial, the add-on TC-5214 arm (TC-5214 + citalopram) outperformed the add-on placebo arm (placebo + citalopram) on the primary outcome measure, the Hamilton Rating Scale for Depression-17, or HAM-D, and all of the secondary outcome measures, with high statistical significance.

Selective serotonin reuptake inhibitors, or SSRIs, are the most commonly prescribed class of drugs for depression, but many patients do not respond well to SSRIs. The National Institute of Mental Health, or NIMH, has estimated that 14.8 million American adults suffer from MDD. In the NIMH's large-scale Sequenced Treatment Alternatives to Relieve Depression, or STAR*D, study, approximately 63% of participants did not achieve remission following initial treatment with citalopram alone.

In the TC-5214 trial, the magnitude of clinical response (change from double blind baseline after eight weeks) on HAM-D was 6.0 points greater for the add-on TC-5214 arm (13.75 point improvement) than for the add-on placebo arm (7.75 point improvement). This result was highly statistically significant (p < 0.0001) on an intent to treat basis. Highly statistically significant results (p < 0.0001) were also achieved on an intent to treat basis on all of the trial's secondary outcome measures, including the Montgomery-Asberg Depression Rating Scale, or MADRS, the Quick Inventory of Depressive Symptomatology Self Reporting scale and assessments of irritability, disability, cognition, severity of illness and global improvement. As previously reported, TC-5214 exhibited a favorable tolerability profile in the trial.

The data from the TC-5214 trial was presented today by Geoffrey C. Dunbar, M.D., Targacept's Vice President, Clinical Development and Regulatory Affairs, at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009), a satellite meeting of the 39th annual meeting of the Society for Neuroscience.

"This clinical trial provides compelling evidence for TC-5214 as a beneficial augmentation treatment with promise for providing relief for millions of patients who do not respond well to first-line SSRI therapy and restoring their quality of life," commented Stuart A. Montgomery, M.D., Emeritus Professor of Psychiatry at the Imperial College School of Science and Medicine, University of London. "The impressive outcomes across the efficacy measures and favorable tolerability profile demonstrated in the trial indicate the potential of TC-5214 to become the augmentation treatment of choice in depression."

"We are excited about the potential of TC-5214 to provide a new mechanistic approach for the treatment of depression. The STAR*D study indicates that nearly two-thirds of subjects do not achieve full relief from depressive symptoms on their initial SSRI medication, and we believe that a well tolerated add-on treatment with strong antidepressant effects would represent a major breakthrough," said J. Donald deBethizy, Ph.D., Targacept's President and Chief Executive Officer. "We have multiple clinical opportunities in addition to TC-5214 that we believe hold great promise, including AZD3480 (TC-1734) in development for ADHD. The tremendous diversity of the NNR class and the broad potential therapeutic applications for our NNR Therapeutics were evident at nAChR2009, reinforcing our mission to develop new medicines to build health and restore independence."

Study Design

The Phase 2b trial of TC-5214 as an augmentation treatment for MDD was a two-phase study conducted at 20 sites in India and three sites in the United States. In the first phase, 579 subjects with MDD received first-line treatment with citalopram hydrobromide for eight weeks, 20mg daily for the first four weeks and 40mg daily for the next four weeks. Citalopram, an approved treatment for MDD marketed in the United States as Celexa, is from the drug class known as selective serotonin reuptake inhibitors. At the end of the eight weeks, subjects whose MADRS score had improved less than 50 percent and was no lower than 17 and whose Clinical Global Impression - Severity of Illness score was no lower than 4 were considered partial or non responders and randomized into the double blind second phase of the trial.

In the double blind second phase, subjects continued their citalopram treatment and also received either add-on TC-5214 or add-on placebo for an additional eight weeks. The daily dosage of TC-5214 was initially 2mg and could be increased at the discretion of the investigator to 4mg and to 8mg based on tolerability and therapeutic response. The primary outcome measure for the trial was mean change between add-on TC-5214 (TC-5214 + citalopram) and add-on placebo (placebo + citalopram) from double blind baseline as measured by HAM-D at week 16. The intent to treat dataset included 265 subjects in the second phase.


'/>"/>

Contact: Michelle Linn
linnmich@comcast.net
508-362-3087
Linnden Communications
Source:Eurekalert

Related biology news :

1. Depression, aging, and proteins made by a virus may all play role in heart disease
2. Newly-identified exercise gene could help with depression
3. New studies on schizophrenia, depression, trauma and autism highlight annual meeting
4. MNI researchers locate neurological basis of depression following sports concussion
5. Why serotonin can cause depression and anxiety
6. Study identifies changes to DNA in major depression and suicide
7. Likely cause of postpartum blues and depression identified
8. Coating improves electrical stimulation therapy used for Parkinsons, depression, chronic pain
9. Coming soon: Self-guided, computer-based depression treatment
10. Depression during pregnancy can double risk of preterm delivery
11. Pregnancy hormone predicts postpartum depression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... YORK , March 21, 2017 ... Marketing Cloud used by retailers such as 1-800-Flowers ... its platform — Product Recommendations and Replenishment. Using Optimove,s ... give more personalized product and replenishment recommendations to ... but also on predictions of customer intent drawn ...
(Date:3/20/2017)... -- PMD Healthcare announces the release of its new ... (WMS), a remote, real-time lung health monitoring and management ... a Medical Device, Digital Health, and Chronic Care Management ... solutions that empower people to improve their healthcare and ... the first ever personal spirometer, Spiro PD, which was ...
(Date:3/9/2017)... , March 9, 2017 4Dx has publicly ... Lung Imaging Workshop at the University of Pennsylvania. Founder ... to deliver the latest data to world leaders in ... brings together leaders at the forefront of the industry ... imaging. "The quality of the imaging ...
Breaking Biology News(10 mins):
(Date:3/23/2017)... ... March 23, 2017 , ... Ellen Matloff, ... Connecticut Technology Council (CTC) as a 2017 Women of Innovation® finalist. Matloff will ... Innovation Awards Dinner. , The dinner recognizes women accomplished in science, technology, engineering ...
(Date:3/23/2017)... NEW YORK , March 23, 2017 ... closer look at four equities in the Biotech industry: ... EYEG), Synthetic Biologics Inc. (NYSE MKT: SYN), and Regulus ... March 21 st , 2017, Credit Suisse upgraded its rating ... stocks by downloading their free report at: ...
(Date:3/22/2017)... Calif. , March 22, 2017  UBM ... proud to announce their extended partnership and the ... be headlined by the 21 st Annual ... Boston, taking place May 3-4, 2017. ... Medical Technology Association (ADVAMED) President and CEO, ...
(Date:3/22/2017)... Florida , March 22, 2017 ... ... various cancer conditions are being pressured as of late due ... for cancer pain management has a dramatic impact on patient,s ... research and development activities for identifying new forms of opioid ...
Breaking Biology Technology: