First Clinical Study of Paliperidone ER in this Under-Studied Condition
SAN DIEGO, Nov. 1 /PRNewswire/ -- Patients with schizoaffective disorder receiving paliperidone extended release tablets (paliperidone ER) for six weeks showed a significant improvement in their symptoms, according to a new study presented today at the U.S. Psychiatric & Mental Health Congress in San Diego, Calif.(1) In addition, safety findings were similar to published studies of paliperidone ER in the treatment of schizophrenia.(2)(3)
"Schizoaffective disorder is an under studied condition that despite being common among patients with serious mental illness, has no approved treatment," said Husseini Manji, M.D., Vice President, Central Nervous System and Pain, Johnson & Johnson Pharmaceutical Research and Development. "This new study suggests that paliperidone ER could be an effective option for the treatment of schizoaffective disorder. Additional studies are needed to confirm this finding."
Schizoaffective disorder is a condition, which encompasses the symptoms of both schizophrenia and a major mood disorder. Patients with schizoaffective disorder experience the psychosis characteristic of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression.(4) Schizoaffective disorder can be difficult to distinguish from schizophrenia or bipolar disorder because the symptoms are similar to both. The disorder is about one third as common as schizophrenia(5) but within those people that frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.(6)
In the 6 week, international, randomized, double-blind, placebo controlled study, 316 patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms, received either 6mg/day or 12mg/day paliperidone ER, or a placebo. Dosages could be reduced to 3mg/day or 9mg/day respectively with the option to increase back to the originally assigned dose. No dose adjustments were permitted after day 15. In addition to study medication, patients were also permitted to receive previously prescribed anti-depressants and/or mood stabilizers during the duration of the trial, if on a stable dosage within 30 days of screening.
The results showed that patients in the higher dose group [11.6 mg/day](a) paliperidone ER had significantly improved symptoms, based on the primary outcome parameter of total change in mean PANSS(b) scores, compared to patients on placebo (p=0.003). The lower dose group [5.7 mg/day](c), however, did not show a statistically significant difference from placebo. Significantly more patients in both the higher and lower dose groups achieved overall response (defined as at least 30% improvement on the PANSS and a Clinical Global Impressions of Change for Schizoaffective Disorder (CGI-C- SCA)(d) of much or very much improved) when compared to patients taking placebo (p less than or equal to 0.008). Further, among patients with prominent mood symptoms as measured by the Young Mania Ratings Scale and the Hamilton Rating Scale for Depression, compared to placebo the higher dose group demonstrated significantly greater improvement in symptoms on mania (p<0.001) and depression (p=0.032), while the low dose group showed greater improvement in symptoms of depression (p=0.013).
The study itself was not designed to compare the relative effect of paliperidone ER as a monotherapy or in combination with anti-depressants and/or mood stabilizers, however, results showed the effect of paliperidone ER was evident in both patients treated with monotherapy and with combination therapy.
The most common adverse events occurring in this trial, at an incidence of over 5%, and twice that of placebo in either the higher dose or lower dose arm of the trial were: tremor, somnolence, dyspepsia, constipation, nasopharyngitis and hypertonia.
Paliperidone ER, an atypical antipsychotic medication, was first approved in the U.S. in December 2006 and is marketed as INVEGA(R). It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U.
The study was sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. markets paliperidone ER in the U.S.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com.
IMPORTANT SAFETY INFORMATION FOR PALIPERIDONE ER
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Paliperidone is not approved for the treatment of patients with dementia- related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with paliperidone and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
One risk of paliperidone is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with paliperidone. Please inform your healthcare professional of any medications or supplements that you are taking.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with paliperidone and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with paliperidone and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with paliperidone. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
Paliperidone and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.
People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking paliperidone. Some people taking paliperidone may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time.
Paliperidone may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while on paliperidone.
Paliperidone should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking paliperidone. Caution should be exercised when paliperidone is administered to a nursing woman.
Paliperidone may affect alertness and motor skills; use caution until the effect of paliperidone is known.
Paliperidone may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Paliperidone should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.
The most common side effects that occurred with paliperidone were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).
(a) Mean modal dose for the higher dose (12mg/day) group
(b) Positive and Negative Syndrome Scale for Schizophrenia (PANSS) is a standard rating scale used in trials to assess the severity of symptoms. The scale consists of 30 items, which are assessed from absent to extreme, and these are divided into both positive and negative symptoms
(c) Mean modal dose for the lower dose (6mg/day) group
(d) Clinical Global Impressions of Severity of Illness for Schizoaffective disorder (CGI-S-SCA) is frequently used in medical care and clinical research. It is 7-point scale measuring measures symptom severity, treatment response and the efficacy of treatments. It requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
(1) Canuso C.M, Lindenmayer J-P, Kosik-Gonzalez C, et al., A Randomized Double Blind. Placebo-Controlled Study of Paliperidone ER in the Treatment of Subjects with Schizoaffective Disorder. Presented at the U.S. Psychiatric and Mental Health Congress in San Diego, California.
(2) Davidson M, et al. Schizophr Res. 2007; 93(1-3): 117-130
(3) Kane J, et al. Schizophr Res 2007; 90 (1-3):147-161
(4) The Mayo Clinic Website: http://www.mayoclinic.com/health/schizoaffective-disorder/DS00866 Assessed October 10 2008
(5) Scully PJ, et al. Schizophr Res. 2004;67(2-3):143-155
(6) Kent S. et al. Psychiatr Serv. 1995; 46(12): 1254-1257
|SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals,Inc.
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