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A Comparison of Long-acting Injectable Medications for Schizophrenia (ACLAIMS)

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ClinicalTrials.gov Identifier: NCT01136772
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : April 24, 2015
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Duke University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Interventions Drug: haloperidol decanoate
Drug: paliperidone palmitate
Enrollment 311
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Palmitate Haloperidol Decanoate
Hide 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 [1] 147 [1]
Completed 41 44
Not Completed 116 110
Reason Not Completed
Adverse Event             15             14
Lack of Efficacy             42             39
Administrative             14             12
Withdrawal by Subject             33             36
Did not receive injection             10             7
Did not follow up after first injection             2             2
[1]
Includes all randomized participants who received at least one dose of the injectable medication
Arm/Group Title Paliperidone Palmitate Haloperidol Decanoate Total
Hide 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 Number of Baseline Participants 145 145 290
Hide Baseline Analysis Population Description
Baseline characteristics of modified intent-to-treat population (those who received at least one injection and attended one follow-up appointment)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 145 participants 290 participants
43  (12.6) 45  (12.3) 44  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
Female
39
  26.9%
35
  24.1%
74
  25.5%
Male
106
  73.1%
110
  75.9%
216
  74.5%
1.Primary Outcome
Title Efficacy Failure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received an injection and attended one follow-up appointment
Arm/Group Title Paliperidone Palmitate Haloperidol Decanoate
Hide Arm/Group Description:
Intramuscular injections of paliperidone palmitate 39-234 mg every month
Intramuscular injections of haloperidol decanoate 25-200 mg every month
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: participants
49 47
2.Secondary Outcome
Title Changes in Psychiatric Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with PANSS scores at 6 months
Arm/Group Title Paliperidone Palmitate Haloperidol Decanoate
Hide Arm/Group Description:
Intramuscular injections of paliperidone palmitate 39-234 mg every month
Intramuscular injections of haloperidol decanoate 25-200 mg every month
Overall Number of Participants Analyzed 91 88
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-6.87
(-8.79 to -4.94)
-6.40
(-8.32 to -4.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Palmitate Haloperidol Decanoate
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Palmitate Haloperidol Decanoate
Affected / at Risk (%) Affected / at Risk (%)
Total   53/147 (36.05%)   45/147 (30.61%) 
Psychiatric disorders     
Suicidal ideation *  20/147 (13.61%)  16/147 (10.88%) 
Suicidal Act *  2/147 (1.36%)  5/147 (3.40%) 
Homicidal ideation *  8/147 (5.44%)  7/147 (4.76%) 
Homocidal Act *  0/147 (0.00%)  1/147 (0.68%) 
Violent ideation *  2/147 (1.36%)  3/147 (2.04%) 
Violent act *  0/147 (0.00%)  2/147 (1.36%) 
Psychiatric hospitalization *  44/147 (29.93%)  34/147 (23.13%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone Palmitate Haloperidol Decanoate
Affected / at Risk (%) Affected / at Risk (%)
Total   100/147 (68.03%)   88/147 (59.86%) 
Cardiac disorders     
Orthostatic faintness  [1]  14/147 (9.52%)  12/147 (8.16%) 
Gastrointestinal disorders     
Dry mouth  [1]  40/147 (27.21%)  34/147 (23.13%) 
Constipation  [1]  21/147 (14.29%)  20/147 (13.61%) 
General disorders     
Increased appetite  [1]  33/147 (22.45%)  26/147 (17.69%) 
Sialorrhea  [1]  24/147 (16.33%)  16/147 (10.88%) 
Psychiatric disorders     
Insomnia  [1]  49/147 (33.33%)  54/147 (36.73%) 
Sleepiness  [1]  41/147 (27.89%)  44/147 (29.93%) 
Hypersomnia  [1]  24/147 (16.33%)  20/147 (13.61%) 
Renal and urinary disorders     
Incontinence/nocturia  [1]  13/147 (8.84%)  8/147 (5.44%) 
Urinary hesitancy  [1]  7/147 (4.76%)  9/147 (6.12%) 
Reproductive system and breast disorders     
Menstrual irregularities  [1]  12/147 (8.16%)  5/147 (3.40%) 
Indicates events were collected by systematic assessment
[1]
Events rated moderate or severe
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.
Results Point of Contact
Name/Title: T. Scott Stroup
Organization: Columbia University
Phone: 646-774-8435
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01136772     History of Changes
Other Study ID Numbers: #6017
R01MH081107 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2010
First Posted: June 3, 2010
Results First Submitted: March 25, 2015
Results First Posted: April 24, 2015
Last Update Posted: October 21, 2016