ACLAIMS: A Comparison of Long-acting Injectable Medications for Schizophrenia

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01136772
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Duke University (Other), University of North Carolina, Chapel Hill (Other)
• Enrollment: 311
• Locations: 22
• Arms: 2
• Duration (Months): 64
• Patients Per Site: 14.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: haloperidol decanoate; Drug: paliperidone palmitate	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparison of Long-Acting Injectable Medications for Schizophrenia
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paliperidone palmitate Intramuscular injections of paliperidone palmitate 39-234 mg every month	Drug: paliperidone palmitate; Paliperidone palmitate injections, 39 mg - 234 mg once a month; Other Names: Invega Sustenna
Active Comparator: Haloperidol decanoate Intramuscular injections of haloperidol decanoate 25-200 mg every month	Drug: haloperidol decanoate; haloperidol decanoate injections, 25-200 mg once a month; Other Names: Haldol

Outcome Measures

Primary Outcome Measures

1. Efficacy Failure [24 months]

   Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.

Secondary Outcome Measures

1. Changes in Psychiatric Symptoms [Baseline to 6 months]

   The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.

Exclusion Criteria:

• 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

• Women who are pregnant or breastfeeding

• Patients with mental retardation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Heathcare Systems	Palo Alto	California	United States	94304
2	Yale University/Connecticut Mental Health Center	New Haven	Connecticut	United States	06519
3	University of Miami School of Medicine	Miami	Florida	United States	33316
4	Medical College of Georgia	Augusta	Georgia	United States	30912
5	University of Iowa Hospital	Iowa City	Iowa	United States	52242
6	Clinical Research Institute	Wichita	Kansas	United States	67207
7	Clinical Insights, Inc.	Glen Burnie	Maryland	United States	21061
8	John D. Dingell VA Medical Center	Detroit	Michigan	United States	48201
9	Sparrow St. Lawrence Hospital, Michigan State University Psychiatry	Lansing	Michigan	United States	48915
10	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri	United States	64128
11	Creighton University Dept. of Psychiatry	Omaha	Nebraska	United States	68131
12	Research Foundation for Mental Hygiene	New York	New York	United States	10032
13	University of Rochester	Rochester	New York	United States	14623
14	John Umstead Hospital/Duke University	Butner	North Carolina	United States	27509
15	University of North Carolina	Chapel Hill	North Carolina	United States	27599-7160
16	Carolina Behavioral Care	Durham	North Carolina	United States	27705
17	Louis Stokes Cleveland VA Medical Center	Brecksville	Ohio	United States	44141
18	Philadelphia VA Medical Center-116A	Philadelphia	Pennsylvania	United States	19104
19	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75235
20	Central Texas Veterans Health Care System	Waco	Texas	United States	78711
21	Frontier Institute	Spokane	Washington	United States	99204
22	VA Puget Sound Health Care System	Tacoma	Washington	United States	98493

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)
• Duke University
• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Scott Stroup, MD, MPH, Columbia University
• Principal Investigator: Joseph P McEvoy, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01136772
• Other Study ID Numbers: #6017; R01MH081107
• First Posted: Jun 3, 2010
• Last Update Posted: Oct 21, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Haloperidol; Paliperidone Palmitate; Haloperidol decanoate

Study Results

Participant Flow

Arm/Group Title	Paliperidone Palmitate	Haloperidol Decanoate
Arm/Group Description	Intramuscular injections of paliperidone palmitate 39-234 mg every month	Intramuscular injections of haloperidol decanoate 25-200 mg every month
Period Title: Overall Study
STARTED	157	154
Safety Population	147	147
COMPLETED	41	44
NOT COMPLETED	116	110

Baseline Characteristics

Arm/Group Title	Paliperidone Palmitate	Haloperidol Decanoate	Total
Arm/Group Description	Intramuscular injections of paliperidone palmitate 39-234 mg every month	Intramuscular injections of haloperidol decanoate 25-200 mg every month	Total of all reporting groups
Overall Participants	145	145	290
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (12.6)	45 (12.3)	44 (12.4)
Sex: Female, Male (Count of Participants)
Female	39 26.9%	35 24.1%	74 25.5%
Male	106 73.1%	110 75.9%	216 74.5%

Outcome Measures

1. Primary Outcome

Title	Efficacy Failure
Description	Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All randomized participants who received an injection and attended one follow-up appointment

Arm/Group Title	Paliperidone Palmitate	Haloperidol Decanoate
Arm/Group Description	Intramuscular injections of paliperidone palmitate 39-234 mg every month	Intramuscular injections of haloperidol decanoate 25-200 mg every month
Measure Participants	145	145
Number [participants]	49 33.8%	47 32.4%

2. Secondary Outcome

Title	Changes in Psychiatric Symptoms
Description	The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

Participants with PANSS scores at 6 months

Arm/Group Title	Paliperidone Palmitate	Haloperidol Decanoate
Arm/Group Description	Intramuscular injections of paliperidone palmitate 39-234 mg every month	Intramuscular injections of haloperidol decanoate 25-200 mg every month
Measure Participants	91	88
Mean (95% Confidence Interval) [Units on a scale]	-6.87	-6.40

Adverse Events

Arm/Group Title	Paliperidone Palmitate		Haloperidol Decanoate
Arm/Group Description	Intramuscular injections of paliperidone palmitate 39-234 mg every month		Intramuscular injections of haloperidol decanoate 25-200 mg every month
All Cause Mortality
	Paliperidone Palmitate		Haloperidol Decanoate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Paliperidone Palmitate		Haloperidol Decanoate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/147 (36.1%)		45/147 (30.6%)
Psychiatric disorders
Suicidal ideation	20/147 (13.6%)		16/147 (10.9%)
Suicidal Act	2/147 (1.4%)		5/147 (3.4%)
Homicidal ideation	8/147 (5.4%)		7/147 (4.8%)
Homocidal Act	0/147 (0%)		1/147 (0.7%)
Violent ideation	2/147 (1.4%)		3/147 (2%)
Violent act	0/147 (0%)		2/147 (1.4%)
Psychiatric hospitalization	44/147 (29.9%)		34/147 (23.1%)
Other (Not Including Serious) Adverse Events
	Paliperidone Palmitate		Haloperidol Decanoate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	100/147 (68%)		88/147 (59.9%)
Cardiac disorders
Orthostatic faintness	14/147 (9.5%)		12/147 (8.2%)
Gastrointestinal disorders
Dry mouth	40/147 (27.2%)		34/147 (23.1%)
Constipation	21/147 (14.3%)		20/147 (13.6%)
General disorders
Increased appetite	33/147 (22.4%)		26/147 (17.7%)
Sialorrhea	24/147 (16.3%)		16/147 (10.9%)
Psychiatric disorders
Insomnia	49/147 (33.3%)		54/147 (36.7%)
Sleepiness	41/147 (27.9%)		44/147 (29.9%)
Hypersomnia	24/147 (16.3%)		20/147 (13.6%)
Renal and urinary disorders
Incontinence/nocturia	13/147 (8.8%)		8/147 (5.4%)
Urinary hesitancy	7/147 (4.8%)		9/147 (6.1%)
Reproductive system and breast disorders
Menstrual irregularities	12/147 (8.2%)		5/147 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.