Completed

ACLAIMSA Comparison of Long-Acting Injectable Medications for Schizophrenia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

haloperidol decanoate

+ paliperidone palmitate

Drug
Who is being recruted

Mental Disorders+1

+ Psychotic Disorders

+ Schizophrenia

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2011
See protocol details

Summary

Principal SponsorNew York State Psychiatric Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2011

Actual date on which the first participant was enrolled.

The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule. This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.

Official TitleA Comparison of Long-Acting Injectable Medications for Schizophrenia
NCT01136772
Principal SponsorNew York State Psychiatric Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

311 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersPsychotic DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

5 inclusion criteria required to participate
Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria

Age 18-65 years

Capacity to provide informed consent

Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate

Show More Criteria

6 exclusion criteria prevent from participating
Patients who are currently stable and doing well on an antipsychotic regimen

Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol

Patients with tardive dyskinesia that is moderate or severe

Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Intramuscular injections of haloperidol decanoate 25-200 mg every month

Group II

Experimental
Intramuscular injections of paliperidone palmitate 39-234 mg every month

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Suspended

VA Palo Alto Heathcare Systems

Palo Alto, United StatesOpen VA Palo Alto Heathcare Systems in Google Maps
Suspended

Yale University/Connecticut Mental Health Center

New Haven, United States
Suspended

University of Miami School of Medicine

Miami, United States
Suspended

Medical College of Georgia

Augusta, United States
Completed22 Study Centers