Clinical trials: Psychotic Symptoms
Schizophrenia
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia.
- Trial name
- NCT00145496
- Testing
- Asenapine, Olanzapine
- Volunteers
- 468 people
- Sponsor
- Organon and Co
Sleep Initiation and Maintenance Disorder; Elderly, Mental Disorder
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and…
- Conditions
- Sleep Initiation and Maintenance Disorder; Elderly, Mental Disorder, Dyssomnias, Sleep Disorders
- Trial name
- Jade (NCT00561574)
- Testing
- Esmirtazapine
- Volunteers
- 259 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar Disorder, Bipolar Affective Psychosis
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
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.
- Conditions
- Bipolar Disorder, Bipolar Affective Psychosis, Mania, Manic Disorder
- Trial name
- EMMY (NCT00521365)
- Testing
- Quetiapine 600mg
- Where
- 7 sites in Mexico
- Volunteers
- 88 people
- Sponsor
- AstraZeneca
Schizophrenia
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability.
- Trial name
- NCT02013622
- Testing
- Brexpiprazole
- Where
- 22 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Ketamine-Induced Brain Activity Changes, Psychotic-like Symptoms
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
- Trial name
- NCT01892189
- Testing
- Ketamine, TAK-063
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in…
- Trial name
- NCT00698022
- Testing
- Risperidone, Mifepristone
- Where
- India
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
Schizophrenia
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.
- Trial name
- NCT01760993
- Testing
- SPD489
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Shire
Schizophrenia
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.
- Trial name
- NCT06572449
- Testing
- KarXT
- Where
- 6 sites in United States
- Volunteers
- 173 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Schizophrenia
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
- Trial name
- NCT00723606
- Testing
- Intramuscular ziprasidone mesylate, Intramuscular haloperidol
- Where
- 9 sites in China
- Volunteers
- 376 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Schizophrenia, Cerebellar Ataxia
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
- Trial name
- NCT02566759
- Testing
- TAK-831 Oral Suspension, TAK-831 Tablet
- Where
- United Kingdom
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Schizophrenia
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
- Trial name
- NCT01412060
- Testing
- Cariprazine
- Where
- 73 sites in United States, India and 3 more
- Volunteers
- 765 people
- Sponsor
- Forest Laboratories
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Antipsychotic-induced Weight Gain (AIWG)
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with…
- Trial name
- GRATITUDE (NCT03818256)
- Testing
- Miricorilant
- Where
- 27 sites in United States
- Volunteers
- 71 people
- Sponsor
- Corcept Therapeutics
Schizophrenia
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute…
- Trial name
- STEP 203 (NCT00905307)
- Testing
- OPC-34712, Aripiprazole
- Where
- 73 sites in United States, Bulgaria and 10 more
- Volunteers
- 459 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
- Trial name
- ATTAIN 267 (NCT01122927)
- Testing
- Aripiprazole
- Where
- 101 sites in United States, Bulgaria and 11 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
- Trial name
- NCT01760889
- Testing
- SPD489 low dose range (40mg, 80mg, and 100mg), SPD489 high dose range (120mg, 140mg and 160mg)
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Shire
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
Psychotic Depression, Severe Major Depression With Psychotic Features
A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by…
- Conditions
- Psychotic Depression, Severe Major Depression With Psychotic Features, Psychosis
- Trial name
- NCT00637494
- Testing
- mifepristone
- Where
- 42 sites in United States
- Volunteers
- 292 people
- Sponsor
- Corcept Therapeutics
Inflammatory Bowel Diseases, Depressive Episode
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years…
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder
- Trial name
- NCT05206734
- Testing
- No specific intervention
- Where
- United Kingdom
- Volunteers
- 19,469 people, healthy volunteers welcome
- Sponsor
- Momentum Data