View clinical trials related to Mania.
Filter by:This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol. The patients are required to be hospitalised for the treatment and assessment defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis. The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit. At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).