NCT01389908

Brief Summary

The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP) Depot in patients diagnosed with schizophrenia or schizoaffective disorder.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 8, 2011

Status Verified

June 1, 2011

Enrollment Period

3.1 years

First QC Date

June 30, 2011

Last Update Submit

July 7, 2011

Conditions

SchizophreniaSchizoaffective Disorders

Outcome Measures

Primary Outcomes (2)

  • blood pressure and pulse

    supine and standing blood pressure and pulse will be measured 10 minutes prior to the injection

    10 minutes prior to the injection

  • blood pressure and pulse

    supine and standing blood pressure and pulse will be measured 15 minutes following the injection

    15 minutes following the injection

Study Arms (1)

schizophrenia

EXPERIMENTAL

schizophrenia or schizoaffective patients

Drug: olanzapine

Interventions

olanzapineDRUG

Patients will receive doses within the range of 280 mg to 405mg OP Depot, according the physician's judgment, on a 3-week interval.

schizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two patients that have been stabilized on OP Depot will be enrolled to the follow-up study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata MHC

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 8, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2014

Last Updated

July 8, 2011

Record last verified: 2011-06

Locations

IL(1)