Clinical trials: Psychotic Mood Disorders
Bipolar Disorder, Schizophrenia
Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®).
- Trial name
- NCT01495741
- Volunteers
- 42 people
- Sponsor
- Organon and Co
Schizophrenia
A Pharmacokinetic Study of the Relative Bioavailability of Paliperidone ER Formulations With Different Release Profiles and a Comparison to Paliperidone IR
The primary purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of paliperidone ER formulations with slow, target, and fast in vitro release rates after administration of a single 12 mg dose.
- Trial name
- NCT00791193
- Testing
- Paliperidone ER
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Schizophrenia, Schizoaffective Disorder
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder
- Trial name
- NCT07105111
- Testing
- Valbenazine
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia, Bipolar Disorder
Bio-equivalence Study Between SAPHRIS and Asenapine
This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.
- Trial name
- ASN (NCT01948024)
- Testing
- SAPHRIS, Asenapine
- Where
- 7 sites in United States
- Volunteers
- 65 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Schizophrenia, Major Depressive Disorder
General Practice Research Database Seroquel XR Safety Study
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- Trial name
- GPRD SeroquelS (NCT01447082)
- Where
- Switzerland
- Volunteers
- 37,372 people
- Sponsor
- AstraZeneca
Psychomotor Agitation, Schizophrenia
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
- Conditions
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
- Trial name
- NCT04148963
- Testing
- Inhaled loxapine
- Volunteers
- 150 people
- Sponsor
- Lee's Pharmaceutical Limited
Schizophrenia, Schizoaffective Disorder
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Trial name
- NCT00303602
- Testing
- Sublingual orally disintegrating olanzapine (SODO), Oral olanzapine
- Where
- 21 sites in United States, Canada and 3 more
- Volunteers
- 149 people
- Sponsor
- Eli Lilly and Company
Schizophrenia
A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville
The purpose of this study is to establish bioequivalence of paliperidone ER tablets manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville, administered as a single dose of 12 mg under fasted…
- Trial name
- NCT00790777
- Testing
- Paliperidone ER
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sleep Initiation and Maintenance Disorders
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
- Trial name
- NCT00374777
- Testing
- zolpidem MR, nitrazepam
- Where
- 6 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Schizophrenia
A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS Paliperidone
The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture on the pharmacokinetics of ER OROS…
- Trial name
- NCT00838669
- Testing
- Extended release OROS paliperidone
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Depressive Disorder, Major
A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress…
- Trial name
- NCT00208156
- Testing
- Mifepristone
- Where
- 13 sites in United States
- Volunteers
- 87 people
- Sponsor
- Corcept Therapeutics
Schizophrenia, Bipolar Disorder
An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community…
- Trial name
- NCT00510211
- Testing
- olanzapine
- Where
- 3 sites in France, Germany and 1 more
- Volunteers
- 1,131 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder, Mood Disorders
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute…
- Trial name
- NCT00309699
- Testing
- Quetiapine, Paliperidone ER
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 493 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Agitation, Schizophrenia
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia.
- Conditions
- Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder
- Trial name
- SERENITY I (NCT04268303)
- Testing
- Sublingual film containing dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc
Depression, Depressive Disorders
A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517.
- Conditions
- Depression, Depressive Disorders, Psychotic Disorders
- Trial name
- Hermes (NCT00212797)
- Testing
- Org 34517
- Volunteers
- 273 people
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia, Drug Abuse
A Pilot, Proof-of-concept Cohort Study of the Prevalence of Comorbid Mental Illness and Substance Abuse
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys.
- Conditions
- Schizophrenia, Drug Abuse, Anxiety Disorder, Bipolar Disorder
- Trial name
- NCT02476877
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Advanced Clinical Laboratory Solutions, Inc.
Schizophrenia, Schizoaffective Disorder
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
- Trial name
- NCT00480571
- Testing
- BL-1020, BL 1020 High Dose
- Where
- 2 sites in Israel, Romania
- Volunteers
- 90 people
- Sponsor
- BioLineRx, Ltd.
Major Depressive Disorder
The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression
The purposes of this study are to determine: Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
- Trial name
- NCT00035321
- Testing
- Olanzapine, Fluoxetine
- Where
- 33 sites in United States, Canada
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
Schizophrenia
Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Subjects
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant.
- Trial name
- MNK112891 (NCT01090440)
- Testing
- GSK1144814
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Affective Psychosis, Bipolar, Mania
Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
- Conditions
- Affective Psychosis, Bipolar, Mania, Manic-Depressive Psychosis
- Trial name
- NCT00454883
- Testing
- ziprasidone
- Volunteers
- 379 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.