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Mania clinical trials

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NCT ID: NCT00521365 Completed - Bipolar Disorder Clinical Trials

Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

EMMY
Start date: May 2008
Phase: Phase 4
Study type: Interventional

The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

NCT ID: NCT00518947 Completed - Mania Clinical Trials

Pharmacotherapy of Treatment-Resistant Mania

TRM
Start date: November 1994
Phase: Phase 3
Study type: Interventional

Verapamil has been found in some but not all studies to have antimanic activity. Therefore, we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients who did not respond to an initial adequate trial of lithium. Each study phase lasted three weeks. Subjects were treated openly with lithium in Phase 1 (n=45). Those who failed to respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil (n=10) or continued lithium (n=8). Phase 2 responders were continued on the same medication in Phase 3. Phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in Phase 3.

NCT ID: NCT00454883 Completed - Mania Clinical Trials

Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

Start date: April 2007
Phase:
Study type: Observational

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

NCT ID: NCT00448578 Completed - Bipolar Disorder Clinical Trials

Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients

STAR
Start date: August 2005
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00431184 Completed - Bipolar Disorder Clinical Trials

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Start date: January 2007
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00422331 Active, not recruiting - Bipolar Disorder Clinical Trials

Safety and Efficacy Study of Lithium in Bipolar Disorder

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.

NCT ID: NCT00422123 Completed - Mania Clinical Trials

Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Start date: January 2007
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00334347 Completed - Mania Clinical Trials

A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR

Start date: June 2006
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00309686 Completed - Bipolar Disorder Clinical Trials

A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder

Start date: April 2006
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00254488 Completed - Bipolar Disorder Clinical Trials

Treatment of Bipolar Mania in Older Adults

GERI-BD
Start date: November 2005
Phase: Phase 4
Study type: Interventional

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.