Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating Vabicaserin in Subjects With Schizophrenia

NCT00563706

Schizophrenia

COMPLETED PHASE2

Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects

NCT00458107

Schizophrenia

COMPLETED PHASE1

Safety, PK and PD Study in Healthy Male Japanese Subjects

NCT00447941

Schizophrenia

COMPLETED PHASE1

Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects

NCT00505973

Schizophrenia

COMPLETED PHASE1

Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects

NCT01268124

Schizophrenia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lowest dose

Group Type EXPERIMENTAL

SCA-136 50mg/day

Intervention Type DRUG

2

Middle dose

Group Type EXPERIMENTAL

SCA-136 150 mg/day

Intervention Type DRUG

3

Highest dose

Group Type EXPERIMENTAL

SCA-136 300mg/day

Intervention Type DRUG

4

Positive Control

Group Type ACTIVE_COMPARATOR

Risperidone 4mg/day

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SCA-136 50mg/day

Intervention Type DRUG

SCA-136 150 mg/day

Intervention Type DRUG

SCA-136 300mg/day

Intervention Type DRUG

Risperidone 4mg/day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects between \>=20 and =\<65 years of age
* Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
* Total PANSS score \>=70 and =\< 120

Exclusion Criteria

* Subjects who are hospitalized against their will
* Current Axis I primary psychiatric diagnosis other than schizophrenia
* A score of 3 on CDSS question 8 which pertains to suicide

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No