NCT01279213

Brief Summary

augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has not been tested until now in randomized controlled trials. This combination is supposed to have therapeutic efficacy in the treatment of resistant schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

July 1, 2009

Enrollment Period

9 months

First QC Date

January 11, 2011

Last Update Submit

January 18, 2011

Conditions

SchizophreniaSchizophrenic DisordersPsychotic Disorder

Outcome Measures

Primary Outcomes (1)

  • bprs

    improvement in scores total BPRS

    12 weeks

Secondary Outcomes (1)

  • cgs

    12 weeks

Study Arms (2)

paliperidone clozapine BPRS

ACTIVE COMPARATOR

patients assigned to clozapine plus paliperidone controls at 6 and 12 weeks

Drug: paliperidone clozapine

clozapine plus placebo BPRS

PLACEBO COMPARATOR

patients assigned to placebo plus clozapine should show less improvement

Drug: paliperidone clozapine

Interventions

paliperidone clozapineDRUG

dose 3 to 12 mg paliperidone ER daily during 12 weeks

clozapine plus placebo BPRSpaliperidone clozapine BPRS

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • resistant schizophrenia failure in therapeutic response to three previous antipsychotic drugs -

You may not qualify if:

  • age upper 50 other psychiatric diagnosis head trauma neurological diseases -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology

Rosario, Santa Fe Province, 2000, Argentina

Location

Related Publications (1)

  • Mortimer AM, Singh P, Shepherd CJ, Puthiryackal J. Clozapine for treatment-resistant schizophrenia: National Institute of Clinical Excellence (NICE) guidance in the real world. Clin Schizophr Relat Psychoses. 2010 Apr;4(1):49-55.

    PMID: 20643629BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • daniel j serrani azcurra, MD

    faculty of psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 19, 2011

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

January 19, 2011

Record last verified: 2009-07

Locations

AR(1)