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TC 5214, a new research molecule by Targacept Inc.
Review by :- Dr. Neelam Kumar Bohra
Successful use of TC 5214 has been announced by Targacept inc. at a press conference on 17 th of july 2009, based on the results of a double blind, placebo controlled, flexible dose Phase 2b clinical trial, for treatment of Major Depression disorder, MDD, in patients who did not respond adequately upon treatment with citalopram alone .Results for both primary outcome measure, based on Hamilton rating scale for depression or HAM-D, and secondary efficacy measure such as assessment of depression, irritability, disability, severity of illness, were hugely in favour of TC 5214, marking a major breakthrough for patients suffering from MDD
Results also showed that the patients treated, started responding to TC 5214 within two weeks of use of an initially dose of 2 mg, growing steadily to 8 mg. The overall tolerability was good and observed side effects were constipation, headache and dizziness. The only serious adverse effect was a seizure experienced by a case study.
Targacept carried out the phase 2b clinical trial through a two phase study. In the first phase, 579 study patients were given first-line treatment with citlopram hydrobromide for eight weeks, 20 mg daily in the initial 4 weeks and 40 mg daily for the latter 4 weeks. In the second phase, the patients received an add on, either TC 5214 with citlopram or a placebo with citlopram, with intial dosage of TC 5214 being 2 mg and increased to 4 mg and 8 mg based on tolerability and therapeutic response shown by the study cases.
The primary measure of the trial was a mean change between the two groups i.e. TC 5214 and citlopram and placebo and citlopram, measured by HAM-D in the 16 th week. The intent to treat dataset included 265 subjects in second phase.
The study was carried out in a total of 27 locations with 3 being in USA and rest in INDIA.
TC 5214 is a nicotinic channel blocker that has unique properties in modulating the alpha4beta2 NNR subtype. Overstimulation of NNR (neuronal nicotinic receptors) causes depressive symptoms and has an impact on memory, attention, moods, pain and so on including cell survival. TC 5214 inhibits the activity of these overstimulated receptors and thus have anti depressant effects.
MDD is a severe mental illness characterised by one or more major depressions and in many cases difficult to cure by conventional methods available. Use of TC 5214 as an augmentation with available methods has proved to be successful in treatment of such cases. This type augmentation may prove very beneficial in treatment of major depression disorder which are difficult to treat with available conventional medicines.
In addition, further trials of the drug are going on in patient with resistant hypertension. This drug may also prove to be beneficial in improvement of cognitive functions. It'll be interesting to see if it can also be tried as an augmentation treatment with other drugs in case of Alzheimer disease.
Dr Neelam Kumar Bohra
Editor DPS website
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THE WAR AGAINST TOBACCO: ROLE OF HEALTH PROFESSIONALS
Tobacco consumption is necessary neither for the maintenance of life nor for the satisfaction of social, cultural or spiritual needs yet world's one-third adult population performs this bizarre act despite generally agreed health risks and acceptance by its users that it is harmful to health.
We have witnessed 100 million tobacco-related deaths in the last century and the toll is likely to be one billion in the 21 st century. According to World Health Organization there are about 1.3 billion tobacco users in the world currently and tobacco smoking is the most common form of tobacco consumption both in terms of prevalence and health consequences. 50% (650 million) of the current tobacco users will eventually die prematurely due to tobacco-related diseases in the next few of decades. It is estimated that by the year 2025, there will be about 10 million tobacco-related deaths world-wide and 70% of these deaths will be from the developing countries alone. These are preventable deaths.
India , the world's second largest consumer and producer of tobacco, has, currently 240 million tobacco users aged 15 years and above (195 million males and 45 million females). In all, 57% of the men and 11% of the women use tobacco in one form or the other.
More than 800 billion beedis and 100 billion cigarettes are consumed every year by 120 million Indians. India 's tobacco problem has serious implications for the country's fragile health-care system. The total cost of just three tobacco-related diseases – coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), and tobacco related cancer – is estimated to be over Rs 308 billion (US$7.2 billion) per year. This is ironic and shocking for a country which is struggling to provide basic health care infrastructure and services to its billion-strong population.
While Indian Government has implemented several measures to control tobacco use over the past decade, these have been mostly piecemeal and ineffective. Despite of ample legal provisions and regulations, it is only since 2007 that more effective anti-tobacco measures such as smoke-free rules have been instituted and implemented.
Need of the hour is to sensitize the physicians to treat those who are already the victims of tobacco use. Every patient coming in contact with a doctor needs to be asked about the history of tobacco use and should be treated after enhancing his motivation to quit. It is more relevant to the psychiatrist as the prevalence of tobacco use is more than double in psychiatric patients.
R.C. Jiloha Director Professor & Head, Department of Psychiatry, GB Pant Hospital, Maulana Azad Medical College & University of Delhi
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