Trial Outcomes & Findings for Short Term Rescue Study of Olanzapine (NCT NCT00186017)
NCT ID: NCT00186017
Last Updated: 2017-05-16
Results Overview
The Clinical Global Impression - bipolar version - overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill
COMPLETED
PHASE4
50 participants
Baseline, 1 Week
2017-05-16
Participant Flow
Participant milestones
| Measure |
Olanzapine/Zyprexa
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa
|
Placebo
Placebo
Olanzapine/Zyprexa
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short Term Rescue Study of Olanzapine
Baseline characteristics by cohort
| Measure |
Olanzapine/Zyprexa
n=23 Participants
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa
|
Placebo
n=22 Participants
Placebo
Olanzapine/Zyprexa
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 12 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Bipolar Subtype
Bipolar 1
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Bipolar Subtype
Bipolar 2
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Bipolar Subtype
Bipolar NOS
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
CGI-BP_OS
|
4.8 units on a scale
STANDARD_DEVIATION .8 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION .8 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION .8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 WeekThe Clinical Global Impression - bipolar version - overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill
Outcome measures
| Measure |
Olanzapine/Zyprexa
n=23 Participants
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
|
Placebo
n=22 Participants
Placebo up to 8 per day for 1 week
|
|---|---|---|
|
Mean Change in CGI-BP-OS After 1 Week of Treatment
|
-1.4 units on a scale
Standard Deviation 0.9
|
.8 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, 1 weekThe Young Mania Rating Scale (YMRS) scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Responses to each item are summed with a higher score indicating more mania symptoms endorsed. Scale:0-60 0=Good 60=Bad
Outcome measures
| Measure |
Olanzapine/Zyprexa
n=23 Participants
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
|
Placebo
n=22 Participants
Placebo up to 8 per day for 1 week
|
|---|---|---|
|
Mean Change in YMRS After 1 Week of Treatment
|
-6.0 units on a scale
Standard Deviation 6.7
|
-3.3 units on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline, 1 weekMontgomery-Asberg Depression Rating Scales (MADRS) is a multi-item clinician tool assessing depression. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Outcome measures
| Measure |
Olanzapine/Zyprexa
n=23 Participants
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
|
Placebo
n=22 Participants
Placebo up to 8 per day for 1 week
|
|---|---|---|
|
Mean Change in MADRS After 1 Week of Treatment.
|
-12.3 units on a scale
Standard Deviation 9.5
|
-6.8 units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline, 1 WeekThe HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A does not provide any standardized probe questions. Despite this,the reported levels of interrater reliability for the scale appear to be acceptable. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Outcome measures
| Measure |
Olanzapine/Zyprexa
n=23 Participants
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
|
Placebo
n=22 Participants
Placebo up to 8 per day for 1 week
|
|---|---|---|
|
Mean Change in Hamilton Anxiety Rating Scales (HAM-A)
|
-7.9 units on a scale
Standard Deviation 6.3
|
-3.8 units on a scale
Standard Deviation 6.1
|
Adverse Events
Olanzapine/Zyprexa
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine/Zyprexa
n=23 participants at risk
Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week
Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
|
Placebo
n=22 participants at risk
Placebo taken in same manner as study drug up to 8 per day for 1 week
|
|---|---|---|
|
Gastrointestinal disorders
Increased appetite
|
52.2%
12/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
22.7%
5/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Tremor
|
47.8%
11/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
9.1%
2/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Sedation
|
60.9%
14/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
59.1%
13/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Gastrointestinal disorders
Dry mouth
|
78.3%
18/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
45.5%
10/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Gastrointestinal disorders
Constipation
|
30.4%
7/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
13.6%
3/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
5/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
13.6%
3/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Headache
|
52.2%
12/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
31.8%
7/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Poor memory
|
60.9%
14/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
50.0%
11/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Psychiatric disorders
Sexual dysfunction
|
17.4%
4/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
36.4%
8/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
9.1%
2/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
9.1%
2/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
4.3%
1/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
0.00%
0/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
0.00%
0/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Nervous system disorders
Cramps
|
4.3%
1/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
0.00%
0/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.3%
1/23
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
0.00%
0/22
Adverse events were systematically collected using a standardized clinical monitoring and treatment form
|
Additional Information
Dr. Terence A. Ketter, MD.
Stanford University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place