Treatment Trials

467 Clinical Trials for Various Conditions

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RECRUITING
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Description

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.

COMPLETED
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
Description

The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine. A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine. Another secondary objective is to characterize the pharmacokinetics of ZYPREXA. The planned duration of the study for each participant is 19 weeks.

COMPLETED
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
Description

This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.

COMPLETED
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Description

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

COMPLETED
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Description

This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

TERMINATED
A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Description

This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

COMPLETED
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
Description

The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment

COMPLETED
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Description

The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.

COMPLETED
Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
Description

This study is dedicated to achieving a better understanding of how to identify patterns that indicate someone might be at high risk for relapse in schizophrenia or schizoaffective disorder. The investigators are utilizing smartphone technology along with on body sensors to achieve this goal. The study will observe participants behavior in their natural environment for a period of 16 weeks or until a signal of relapse is obtained. Participants will also complete scales in a clinical research environment biweekly.

COMPLETED
An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder
Description

A review of the amount of drug in your blood over time.

COMPLETED
Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder
Description

The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the safety and tolerability and preliminary efficacy of LY03004 following intramuscular injection.

COMPLETED
Kuvan in People With Schizophrenia and Schizoaffective Disorder
Description

Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical response to Kuvan treatment including negative symptom and cognitive deficits, evaluate safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of changes in plasma Kuvan levels and efficacy outcomes.

COMPLETED
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

COMPLETED
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
Description

The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.

COMPLETED
RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
Description

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

COMPLETED
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Description

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold: * To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo * To determine the effect of moxifloxacin on QTcI * To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

COMPLETED
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.

COMPLETED
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Description

This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.

COMPLETED
Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
Description

The investigators hypothesize that cognitive remediation will be superior to the active control group on the change from baseline to study end point of cognitive remediation phase on both co-primary outcome measures (standardized composite MATRICS score and Cognitive Assessment Interview).

Conditions
COMPLETED
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
Description

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

COMPLETED
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Description

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

COMPLETED
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
Description

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams \[mg\] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Conditions
COMPLETED
A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder
Description

The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder.

WITHDRAWN
Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
Description

This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.

Conditions
TERMINATED
Treatment of Schizoaffective Disorder Using Mifepristone
Description

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

COMPLETED
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Description

Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.

COMPLETED
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
Description

The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

Conditions
COMPLETED
Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine
Description

Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar disorder.

COMPLETED
Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder
Description

The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.

COMPLETED
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Description

The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.