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Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

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ClinicalTrials.gov Identifier: NCT00330863
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Northwell Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Risperidone microspheres
Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Ziprasidone
Drug: Aripiprazole
Drug: Paliperidone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
357 individuals consented to participation. However, 52 were either ineligible, withdrew consent, or lost to followup. Therefore, 305 individuals were randomized.

Reporting Groups
  Description
Injectable

Participants assigned to receive long-acting injectable risperidone

Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

Oral

Participants assigned to receive oral "atypical" antipsychotic medication

Risperidone: Target dose is 4 mg/day.

Olanzapine: Target dose is 15 mg/day.

Quetiapine: Target dose is 600 mg/day.

Ziprasidone: Target dose is 120 mg/day.

Aripiprazole: Target dose is 20 mg/day.

Paliperidone: Target dose is 6 mg/day.


Participant Flow:   Overall Study
    Injectable   Oral
STARTED   153   152 
COMPLETED   72   72 
NOT COMPLETED   81   80 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Injectable

Participants assigned to receive long-acting injectable risperidone

Risperidone microspheres: Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

Oral

Participants assigned to receive oral "atypical" antipsychotic medication

Risperidone: Target dose is 4 mg/day.

Olanzapine: Target dose is 15 mg/day.

Quetiapine: Target dose is 600 mg/day.

Ziprasidone: Target dose is 120 mg/day.

Aripiprazole: Target dose is 20 mg/day.

Paliperidone: Target dose is 6 mg/day.

Total Total of all reporting groups

Baseline Measures
   Injectable   Oral   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   152   305 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.18  (11.8)   38.23  (12.3)   38.2  (12.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      45  29.4%      42  27.6%      87  28.5% 
Male      108  70.6%      110  72.4%      218  71.5% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   81   78   159 
African American   45   40   85 
Hispanic   27   31   58 
Other   0   3   3 
Region of Enrollment 
[Units: Participants]
     
United States   153   152   305 
Clinical Global Impressions (CGI) Severity Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.1  (0.84)   4.0  (0.77)   4.04  (0.80) 
[1]

The Clinical Global Impressions Severity Scale is one item completed by a clinician rater. "Considering your total clinical experience with this patient population, how mentally ill is the patient at this time?" The seven possible ratings are as follows.

  1. = Normal, not at all.
  2. = Borderline mentally ill.
  3. = Mildly ill.
  4. = Moderately ill.
  5. = Markedly ill.
  6. = Severely ill
  7. = Among the most extremely ill patients.


  Outcome Measures

1.  Primary:   Substantial Clinical Deterioration Measured by Psychotic Symptoms   [ Time Frame: Measured throughout study up to 30 months ]

2.  Secondary:   Number of Patients Discontinuing From the Study   [ Time Frame: Measured throughout study up to 30 months ]

3.  Secondary:   Number of Days in Hospital   [ Time Frame: Measured throughout study up to 30 months ]

4.  Secondary:   Control of Psychiatric Symptoms   [ Time Frame: Measured throughout study up to 30 months ]

5.  Secondary:   Quality of Life Measures   [ Time Frame: Measured throughout study up to 30 months ]

6.  Secondary:   Side Effects and Metabolic Measures   [ Time Frame: Measured throughout study up to 30 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter F. Buckley, MD
Organization: Medical College of Georgia, Georgia Regents University
phone: 706-721-2231
e-mail: pbuckley@gru.edu


Publications of Results:

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT00330863     History of Changes
Other Study ID Numbers: U01MH070007-01 ( U.S. NIH Grant/Contract )
U01MH070007-01 ( U.S. NIH Grant/Contract )
U01MH070023 ( U.S. NIH Grant/Contract )
U01MH070011 ( U.S. NIH Grant/Contract )
U01MH070009 ( U.S. NIH Grant/Contract )
U01MH070008 ( U.S. NIH Grant/Contract )
U01MH070017 ( U.S. NIH Grant/Contract )
U01MH070010 ( U.S. NIH Grant/Contract )
U01MH070016 ( U.S. NIH Grant/Contract )
U01MH070012 ( U.S. NIH Grant/Contract )
DSIR 83-ATAP ( Other Grant/Funding Number: National Institute of Mental Health )
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: September 4, 2015
Results First Posted: July 10, 2018
Last Update Posted: July 10, 2018