Safety amd tolerability of ocaperidone in the continuation treatment of patients with schizophrenia: a double-blind, parallel group, multicentre, fixed dose, follow-up study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003776-10-LV

Enrollment

Registered

2005-01-24

Start date

2004-10-22

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The population of the study will be: - schizophrenic patients according to DSM IV-TR diagnosis - have to present the first symptoms of the schizophrenia for at least one year - have to present an exacerbation of the disease or biological/ ECG abnormality which might create a risk for the patient, obscure the effects of study treatment or interfere with drug absorption, metabolism or excretion

Interventions

Product Name: Ocaperidone Pharmaceutical Form: Tablet INN or Proposed INN: Ocaperidone CAS Number: 129029-23-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients who completed study N3D/FOR-OCA-05; - patients who are BPRS responders and tolerated treatment well in study N3D/FOR-OCA-05; - patients must have given written informed consent prior to screening assessments; - a legal representative (guardian or relative) can consent on behalf of the patient if he/she is unable to provide written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - any patient who was never included in study N3D/FOR-OCA-05 - any patient who had a premature termination in prior study N3D/FOR-OCA-05 must not be included in N3D/FOR-OCA-08 study

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of ocaperidone, olanzapine (for patients coming from N3D/FOR-OCA-06 study), or placebo (for patients coming from N3D/FOR-OCA-05 study), in schizophrenic patients for a total treatment duration of 6 months.;Secondary Objective: -To assess the effects of ocaperidone (olanzapine or placebo) on weight in schizophrenic patients -To assess PANSS scores (global and subscores) and BPRS (global and item scores);Primary end point(s): Adverse events, ECG, vital signs, oral temperature, physical examination, prolactin, haematology and biochemistry parametres, Simpson and Angus scale	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of ocaperidone, olanzapine (for patients coming from N3D/FOR-OCA-06 study), or placebo (for patients coming from N3D/FOR-OCA-05 study), in schizophrenic patients for a total treatment duration of 6 months.;Secondary Objective: -To assess the effects of ocaperidone (olanzapine or placebo) on weight in schizophrenic patients -To assess PANSS scores (global and subscores) and BPRS (global and item scores);Primary end point(s): Adverse events, ECG, vital signs, oral temperature, physical examination, prolactin, haematology and biochemistry parametres, Simpson and Angus scale

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Countries

Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026