Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder

... antipsychotic, in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young mania Rating Scale (YMRS), the data showed that ... of cariprazine monotherapy in patients with acute mania associated with bipolar I disorder. During ...

Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder

... symptoms at baseline with the exception of mania for which the RG2417 group mania score was significantly higher (p=0.01). The ... mood can alternate between the "poles" of mania and depression. Bipolar disorder affects more ...

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

... shown to be effective in two short-term bipolar mania studies with a nine-week extension and in two ... over 3,000 patients and has included bipolar mania and acute schizophrenia trials. "Based on ... Treatment response was measured using the Young mania Rating Scale (YMRS) score, an 11-item scale used ...

AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression

... associated with bipolar disorder. The bipolar mania submission is based on a clinical study of ... with a primary endpoint of change in YMRS (Young mania Rating Scale) total score (week 3), in ... SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression ...

Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA

... FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar ... far has consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients. ... is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme ...

Repligen Reports Positive Phase 2a Clinical Trial Results of RG2417 for Symptoms of Bipolar Disorder

... their symptoms at baseline with the exception of mania for which the RG2417 group mania score was significantly higher (p=0.01). The ... included a statistically significant decrease in mania score as determined using the Young Mania Rating ...

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

... program involving more than 3,000 patients in schizophrenia and bipolar mania trials, and is supported by safety data in 4,500 patients, with some ... known as manic depression) is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, decreased sleep and ...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

... A mixed bipolar state occurs when symptoms of depression and mania are experienced at the same time(3). In addition to the two ... use in adults in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, ...

Study Suggests New Treatment Approach May be Needed for Management of Depression in Some People With Bipolar Disorder

... with bipolar depression more likely to experience treatment-emergent mania (TEM). Bipolar disorder, also known as manic-depressive illness, is a ... at risk for developing this problem," says Dr. Frye. People experiencing mania often exhibit poor judgment and impulsivity that can lead them to engage ...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

... symptoms of schizophrenia, such as hallucinations or delusions, as well as mania and/or depression. Because of the similarity in symptoms, schizoaffective ... prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more ...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

... dose group demonstrated significantly greater improvement in symptoms on mania (p<0.001) and depression (p=0.032), while the low dose group showed ... prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... company in the U.S. dedicated solely to mental health. It currently has 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/ . About ...

Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression

... mania, hypomania, depression and suicidal ideation were comparable between the NUVIGIL and placebo groups. There were two serious adverse events of mania in the placebo group but none in the NUVIGIL group. Other adverse events that occurred more frequently in the NUVIGIL versus the placebo group ...

U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

... New Drug Application (NDA) for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials. Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and ...

New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months

... sadness/crying, twitching, weight loss, nausea, vomiting, tics and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using DAYTRANA. ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... adverse events associated with the use of SEROQUEL versus placebo in clinical trials as adjunct therapy with lithium or divalproex in bipolar mania were somnolence (34% vs 9%), dry mouth (19% vs 3%), asthenia (10% vs 4%), constipation (10% vs 5%), abdominal pain (7% vs 3%), postural hypotension ...

Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder

... decreased their average scores (p<0.01 compared to placebo) on the study's primary outcome measure for manic symptom severity, the Young mania Rating Scale (YMRS). Fifty-six percent of patients in the divalproex group, 41 percent of those in the lithium group and 30 percent of the placebo ...

Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia

... over the coming months. Additionally, the Companies expect to receive topline results for the proof of concept study for RGH-188 in bipolar mania in by the middle of calendar 2008. About RGH-188 RGH-188 (INN: cariprazine) discovered by researchers at Gedeon Richter, is a novel antipsychotic ...

Organon's Asenapine Effective in a Phase III Study for the Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA Meeting

... the trial. "The consequences of untreated mania in patients with bipolar disorder can be ... (31%) of bipolar I disorder and a baseline Young mania Rating Scale (YMRS) score greater than or equal ... be effective and safe in the treatment of acute mania associated with bipolar I disorder in this study. ...

Six-Week Investigational Study In Adults With Major Depressive Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole Therapy With Antidepressants

... respectively): Aripiprazole Oral In 3-week bipolar mania trials the following were reported: akathisia (15% vs 3%), ... patients with agitation associated with schizophrenia or bipolar mania the following was reported: nausea (9% vs 3%). ...

Investigational Study Evaluates the Effectiveness of Aripiprazole in Adolescents With Schizophrenia

... placebo, respectively): Aripiprazole Oral In 3-week bipolar mania trials the following were reported: akathisia (15% vs 3%), ... in patients with agitation associated with schizophrenia or bipolar mania the following was reported: nausea (9% vs 3%). ...

Study Sheds Light on Medication Treatment Options for Bipolar Disorder

... with mood stabilizers such as lithium, valproate, carbamazepine or other medications that reduce mania. However, depression is more common than mania in bipolar disorder, and depressive episodes tend to last longer than episodes of mania. Antidepressant medications are often used in addition to a ...

UCLA: Lithium Builds Gray Matter in Bipolar Brains, UCLA Study Shows

... and controlling emotions. The neurobiological underpinnings of bipolar disorder — an illness marked by a roller coaster of emotions between mania and depression — are not well understood. Nor is it understood how lithium works in controlling these severe mood swings, even though it has ...

Bipolar Disorder in Children Difficult to Diagnose, Reports the Harvard Mental Health Letter

... issue of the Harvard Mental Health Letter. Children, especially young children, usually do not show the adult cycle of distinct mood episodes of mania and depression. Also, many symptoms that may stem from bipolar disorder also occur in other childhood disorders: moods fluctuating in very ...