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Switching Medication to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044655
Recruitment Status : Completed
First Posted : September 5, 2002
Results First Posted : December 5, 2013
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Risperidone
Drug: Olanzapine
Drug: Ziprasidone
Drug: Quetiapine
Drug: Aripiprazole
Enrollment 219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stay Switch
Hide Arm/Group Description Participants will continue taking medication prescribed at study entry Participants will change medications from medication prescribed at study entry
Period Title: Overall Study
Started 102 117
Completed 82 79
Not Completed 20 38
Arm/Group Title Stay Switch Total
Hide Arm/Group Description Participants will continue taking medication prescribed at study entry Participants will change medications from medication prescribed at study entry Total of all reporting groups
Overall Number of Baseline Participants 102 117 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 117 participants 219 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
96
  94.1%
112
  95.7%
208
  95.0%
>=65 years
6
   5.9%
5
   4.3%
11
   5.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 117 participants 219 participants
46.9  (10.4) 47.7  (11.3) 46.9  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 117 participants 219 participants
Female
42
  41.2%
31
  26.5%
73
  33.3%
Male
60
  58.8%
86
  73.5%
146
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants 117 participants 219 participants
102 117 219
1.Primary Outcome
Title Number Who Discontinued Medication Within First 6 Study Months
Hide Description [Not Specified]
Time Frame Measured at Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy
Arm/Group Title Stay Switch
Hide Arm/Group Description:
Participants will continue taking medication prescribed at study entry
Participants will change medications from medication prescribed at study entry
Overall Number of Participants Analyzed 92 97
Measure Type: Number
Unit of Measure: participants
11 23
2.Secondary Outcome
Title Psychiatric Symptoms, Hospitalization, and Medication Side Effects
Hide Description [Not Specified]
Time Frame Measured at Year 1
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stay Switch
Hide Arm/Group Description Participants will continue taking medication prescribed at study entry Participants will change medications from medication prescribed at study entry
All-Cause Mortality
Stay Switch
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Stay Switch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      2/117 (1.71%)    
Cardiac disorders     
Death  [1]  0/102 (0.00%)  0 1/117 (0.85%)  1
Psychiatric disorders     
Psychiatric Hospitalization  [2]  0/102 (0.00%)  0 1/117 (0.85%)  1
Indicates events were collected by systematic assessment
[1]
Site PI learned that the 69 year old participant had died following recurrent episodes of bleeding from cerebral aneurism that was diagnosed, but unknown to the site PI, prior to study enrollment (randomized to injectable risperidone)
[2]
Following medication change, participant's prescriber called Project Director to report that the participant was not doing well and was hospitalized subsequent to symptom exacerbation; prescriber changed client's antipsychotic medication regime.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stay Switch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      0/117 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Nancy H. Covell, Ph.D.
Organization: NYSPI
Phone: 6469450227
EMail: covelln@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00044655    
Other Study ID Numbers: GCO 98-924
R01MH059312 ( U.S. NIH Grant/Contract )
First Submitted: September 3, 2002
First Posted: September 5, 2002
Results First Submitted: September 27, 2013
Results First Posted: December 5, 2013
Last Update Posted: April 28, 2016