Trial Outcomes & Findings for Ziprasidone And Olanzapine's Outcomes In Mania (NCT NCT00329108)
NCT ID: NCT00329108
Last Updated: 2021-03-29
Results Overview
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-03-29
Participant Flow
47 centers in Europe.
After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine.
Participant milestones
| Measure |
Ziprasidone
Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
|
Olanzapine
Olanzapine was started at 15 mg/day (15 mg once daily \[QD\]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Ziprasidone
Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
|
Olanzapine
Olanzapine was started at 15 mg/day (15 mg once daily \[QD\]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
symptomatic deterioration
|
1
|
1
|
|
Overall Study
Subject no longer willing to participate
|
2
|
2
|
|
Overall Study
study terminated by sponsor
|
1
|
0
|
|
Overall Study
withdrew patient after SAE resolved
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Ziprasidone And Olanzapine's Outcomes In Mania
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=15 Participants
Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
|
Olanzapine
n=14 Participants
Olanzapine was started at 15 mg/day (15 mg once daily \[QD\]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4, 6 and 10 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Ziprasidone
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Olanzapine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone
Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
|
Olanzapine
Olanzapine was started at 15 mg/day (15 mg once daily \[QD\]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
|
|---|---|---|
|
Eye disorders
Oculogyric crisis
|
6.7%
1/15
|
0.00%
0/14
|
|
General disorders
Disease progression
|
6.7%
1/15
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
6.7%
1/15
|
0.00%
0/14
|
Other adverse events
| Measure |
Ziprasidone
Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion.
|
Olanzapine
Olanzapine was started at 15 mg/day (15 mg once daily \[QD\]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15
|
7.1%
1/14
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15
|
14.3%
2/14
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
gingivitis
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
nausea
|
6.7%
1/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
vomiting
|
6.7%
1/15
|
7.1%
1/14
|
|
General disorders
fatigue
|
0.00%
0/15
|
14.3%
2/14
|
|
General disorders
pyrexia
|
0.00%
0/15
|
7.1%
1/14
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/15
|
7.1%
1/14
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/15
|
7.1%
1/14
|
|
Infections and infestations
pneumonia bacterial
|
0.00%
0/15
|
7.1%
1/14
|
|
Infections and infestations
tonsillitis
|
0.00%
0/15
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
joint dislocation
|
0.00%
0/15
|
7.1%
1/14
|
|
Investigations
weight increased
|
6.7%
1/15
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
fluid retention
|
0.00%
0/15
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
hyperlipidaemia
|
0.00%
0/15
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
increased appetite
|
0.00%
0/15
|
14.3%
2/14
|
|
Nervous system disorders
headache
|
6.7%
1/15
|
7.1%
1/14
|
|
Nervous system disorders
hypotonia
|
0.00%
0/15
|
7.1%
1/14
|
|
Nervous system disorders
somnolence
|
20.0%
3/15
|
7.1%
1/14
|
|
Nervous system disorders
tremor
|
6.7%
1/15
|
21.4%
3/14
|
|
Psychiatric disorders
anxiety
|
6.7%
1/15
|
7.1%
1/14
|
|
Psychiatric disorders
binge eating
|
0.00%
0/15
|
7.1%
1/14
|
|
Psychiatric disorders
delusion
|
0.00%
0/15
|
7.1%
1/14
|
|
Psychiatric disorders
depressed mood
|
6.7%
1/15
|
0.00%
0/14
|
|
Psychiatric disorders
depression
|
0.00%
0/15
|
7.1%
1/14
|
|
Psychiatric disorders
insomnia
|
13.3%
2/15
|
0.00%
0/14
|
|
Psychiatric disorders
mania
|
6.7%
1/15
|
0.00%
0/14
|
|
Reproductive system and breast disorders
breast enlargement
|
0.00%
0/15
|
7.1%
1/14
|
|
Reproductive system and breast disorders
sexual dysfunction
|
0.00%
0/15
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/15
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/15
|
7.1%
1/14
|
|
Surgical and medical procedures
tooth extraction
|
0.00%
0/15
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER