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Trial record 40 of 119 for:    zolpidem AND Hypnotics

Zolpidem CR and Hospitalized Patients With Dementia

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ClinicalTrials.gov Identifier: NCT00814502
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kaloyan Tanev, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dementia
Alzheimer Disease
Dementia, Vascular
Sleep Disorders
Circadian Dysregulation
Interventions Drug: Zolpidem CR
Drug: Placebo
Enrollment 20

Recruitment Details Subjects were recruited from among the patients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11. Inclusion criteria included age between 60-99 years and a clinical diagnosis of Alzheimer's dementia and/or vascular dementia using DSM-IV criteria.
Pre-assignment Details 3 subjects signed informed consent (IC) but were never randomized, and are not included in the table below. One changed his mind prior to randomization; another had untreated sleep apnea, discovered the day after he signed IC; the IC of a third subject was not received from her health care proxy until after her discharge from the hospital.
Arm/Group Title Zolpidem CR Placebo
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Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Period Title: Overall Study
Started 8 9
Completed 7 7
Not Completed 1 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             0             2
Arm/Group Title Zolpidem CR Placebo Total
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Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Age > = 60
8
 100.0%
9
 100.0%
17
 100.0%
Age < 60
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
3
  37.5%
4
  44.4%
7
  41.2%
Male
5
  62.5%
5
  55.6%
10
  58.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
  50.0%
5
  55.6%
9
  52.9%
Unknown or Not Reported
4
  50.0%
4
  44.4%
8
  47.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  11.1%
1
   5.9%
White
7
  87.5%
8
  88.9%
15
  88.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
1
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
1.Primary Outcome
Title Sleep Efficiency
Hide Description

Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100*sleep minutes)/[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)].

The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.

Time Frame Post-intervention, up to 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem CR Placebo
Hide Arm/Group Description:

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Overall Number of Participants Analyzed 8 9
Least Squares Mean (Standard Error)
Unit of Measure: percentage of sleep (see above)
75.93  (3.24) 75.30  (3.14)
2.Primary Outcome
Title Sleep Minutes
Hide Description

Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep.

The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.

Time Frame post-intervention, up to 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem CR Placebo
Hide Arm/Group Description:

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Overall Number of Participants Analyzed 8 9
Least Squares Mean (Standard Error)
Unit of Measure: sleep minutes
443.71  (30.11) 422.49  (29.27)
3.Secondary Outcome
Title Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
Hide Description

Rating Scale for Aggressive Behavior in the Elderly (RAGE, 0-61); higher is worse.

Disruptive Behavior Rating Scales (DBRS, 0-105); higher is worse.

Neuropsychiatric Inventory (NPI, 0-144) – measures 12 different domains of neuropsychiatric symptoms such as delusions, hallucinations, anxiety, depression, apathy, etc.; higher is worse.

Montgomery-Asberg Depression Rating Scale (MADRS, 0-90); higher is worse.

Mini-mental state examination (MMSE, 0-30); higher is better.

The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the firs

Time Frame post-intervention, up to 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem CR Placebo
Hide Arm/Group Description:

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Overall Number of Participants Analyzed 8 9
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
NPI Total Score 18.00  (5.72) 18.64  (5.36)
RAGE Total Score 1.40  (1.31) 5.82  (2.07)
DBRS Total Score 22.64  (0.56) 22.47  (0.58)
MMSE Total Score 24.45  (2.05) 21.57  (1.93)
MADRS Total Score 22.96  (4.75) 22.56  (4.80)
Time Frame Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse Event Reporting Description Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
 
Arm/Group Title Zolpidem CR Placebo
Hide Arm/Group Description

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Subjects randomized to Placebo

Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

All-Cause Mortality
Zolpidem CR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem CR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem CR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      2/9 (22.22%)    
Nervous system disorders     
Dizziness  [1]  2/8 (25.00%)  1/9 (11.11%) 
Confusion  [2]  0/8 (0.00%)  2/9 (22.22%) 
Feeling "foggy" or tired   1/8 (12.50%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Dizziness, or unsteadiness
[2]
Confusion, disorientation
Small sample size. We were unable to control for different treatments that our subjects received as inpatients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kaloyan Tanev, M.D.
Organization: Massachusetts General Hospital
Phone: 617-726-7511
Responsible Party: Kaloyan Tanev, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00814502     History of Changes
Other Study ID Numbers: 2008-P-001434/1
First Submitted: December 18, 2008
First Posted: December 25, 2008
Results First Submitted: February 2, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017