Trial Outcomes & Findings for Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031 (NCT NCT00174447)
NCT ID: NCT00174447
Last Updated: 2021-03-24
Results Overview
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
Ziprasidone
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Ziprasidone
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Overall Study
Adverse Event
|
19
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Administrative reason/Other
|
2
|
Baseline Characteristics
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]Population: Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Outcome measures
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Baseline (n=43): very much improved
|
13 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Baseline (n=43): much improved
|
30 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 months (n=35): very much improved
|
10 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 months (n=35): much improved
|
20 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 months (n=35): minimally improved
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 months (n=35): no change
|
3 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
6 months (n=34): very much improved
|
11 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
6 months (n=34): much improved
|
18 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
6 months (n=34): minimally improved
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
6 months (n=34): no change
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
6 months (n=34): minimally worsened
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
1 year (n=27): very much improved
|
7 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
1 year (n=27): much improved
|
16 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
1 year (n=27): minimally improved
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
1 year (n=27): no change
|
3 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 years (n=10): very much improved
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 years (n=10): much improved
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 years (n=10): no change
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
3 years (n=10): minimally worsened
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
5 years (n=7): very much improved
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
5 years (n=7): much improved
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
5 years (n=7): minimally improved
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): very much improved
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): much improved
|
17 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): minimally improved
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): no change
|
6 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): minimally worsened
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
End of Study [LOCF] (n=43): much worsened
|
6 participants
|
PRIMARY outcome
Timeframe: Baseline, up to 5 years (End of Study [LOCF])Population: ITT. LOCF.
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Change From Baseline in CGI-I at End of Study (up to 5 Years)
|
1.4 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]Population: ITT. LOCF.
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Baseline (n=43): normal, not ill at all
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Baseline (n=43): borderline
|
20 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Baseline (n=43): mildly ill
|
14 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Baseline (n=43): moderately ill
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Baseline (n=43): markedly ill
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 months (n=35): normal, not ill at all
|
6 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 months (n=35): borderline
|
13 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 months (n=35): mildly ill
|
10 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 months (n=35): moderately ill
|
6 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
6 months (n=34): normal, not ill at all
|
8 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
6 months (n=34): borderline
|
10 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
6 months (n=34): mildly ill
|
11 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
6 months (n=34): moderately ill
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
1 year (n=27): normal, not ill at all
|
6 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
1 year (n=27): borderline
|
10 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
1 year (n=27): mildly ill
|
9 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
1 year (n=27): moderately ill
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 years (n=10): normal, not ill at all
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 years (n=10): borderline
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 years (n=10): mildly ill
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
3 years (n=10): moderately ill
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
5 years (n=7): normal, not ill at all
|
1 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
5 years (n=7): borderline
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
5 years (n=7): mildly ill
|
2 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43): normal, not ill at all
|
4 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43): borderline
|
9 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43): mildly ill
|
9 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43): moderately ill
|
10 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43):markedly ill
|
8 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
End of Study [LOCF] (n=43): severely ill
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline, up to 5 years (End of Study [LOCF])Population: ITT. LOCF.
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Change From Baseline in CGI-S at End of Study (up to 5 Years)
|
0.9 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, up to 5 years (End of Study)Population: ITT
Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.
Outcome measures
| Measure |
Ziprasidone
n=43 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
Baseline (n=43): much better
|
28 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
Baseline (n=43): slightly better
|
13 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
Baseline (n=43): about the same
|
2 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
End of study (n=28): much better
|
4 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
End of study (n=28): slightly better
|
8 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
End of study (n=28): about the same
|
8 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
End of study (n=28): slightly worse
|
3 participants
|
|
Number of Participants With Scores on Patient Preference Scale (PPS)
End of study (n=28): much worse
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, up to 5 years (End of Study)Population: ITT. n= number of participants with analyzable data.
DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=24 Participants
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)
|
-3.3 score on a scale
Standard Deviation 4.6
|
Adverse Events
Ziprasidone
Serious events: 13 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone
n=43 participants at risk
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Psychiatric disorders
Schizophrenia
|
9.3%
4/43
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43
|
|
Psychiatric disorders
Depression
|
2.3%
1/43
|
|
Psychiatric disorders
Drug abuse
|
2.3%
1/43
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/43
|
|
Psychiatric disorders
Panic attack
|
2.3%
1/43
|
|
Psychiatric disorders
Psychotic disorder
|
2.3%
1/43
|
|
Psychiatric disorders
Schizoaffective disorder
|
2.3%
1/43
|
|
Psychiatric disorders
Sleep disorder
|
2.3%
1/43
|
|
Renal and urinary disorders
Urinary incontinence
|
4.7%
2/43
|
|
Gastrointestinal disorders
Faecal incontinence
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.3%
1/43
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/43
|
Other adverse events
| Measure |
Ziprasidone
n=43 participants at risk
Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
|
|---|---|
|
Psychiatric disorders
Anxiety
|
23.3%
10/43
|
|
Psychiatric disorders
Schizophrenia
|
14.0%
6/43
|
|
Psychiatric disorders
Insomnia
|
16.3%
7/43
|
|
Psychiatric disorders
Depression
|
11.6%
5/43
|
|
Psychiatric disorders
Depressed mood
|
11.6%
5/43
|
|
Psychiatric disorders
Panic attack
|
4.7%
2/43
|
|
Psychiatric disorders
Sleep disorder
|
4.7%
2/43
|
|
Psychiatric disorders
Hallucination
|
4.7%
2/43
|
|
Psychiatric disorders
Schizoaffective disorder
|
2.3%
1/43
|
|
Psychiatric disorders
Abulia
|
2.3%
1/43
|
|
Psychiatric disorders
Alcoholism
|
2.3%
1/43
|
|
Psychiatric disorders
Libido decreased
|
2.3%
1/43
|
|
Psychiatric disorders
Libido increased
|
2.3%
1/43
|
|
Psychiatric disorders
Middle insomnia
|
2.3%
1/43
|
|
Psychiatric disorders
Psychomotor retardation
|
2.3%
1/43
|
|
Psychiatric disorders
Reactive psychosis
|
2.3%
1/43
|
|
Psychiatric disorders
Stress
|
2.3%
1/43
|
|
Nervous system disorders
Headache
|
9.3%
4/43
|
|
Nervous system disorders
Extrapyramidal disorder
|
4.7%
2/43
|
|
Nervous system disorders
Parkinsonism
|
4.7%
2/43
|
|
Nervous system disorders
Sensory disturbance
|
4.7%
2/43
|
|
Nervous system disorders
Akathisia
|
2.3%
1/43
|
|
Nervous system disorders
Dyskinesia
|
2.3%
1/43
|
|
Nervous system disorders
Somnolence
|
2.3%
1/43
|
|
Nervous system disorders
Tremor
|
2.3%
1/43
|
|
Investigations
Weight decreased
|
11.6%
5/43
|
|
Investigations
Weight increased
|
9.3%
4/43
|
|
Infections and infestations
Influenza
|
4.7%
2/43
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43
|
|
Infections and infestations
Folliculitis
|
2.3%
1/43
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/43
|
|
Infections and infestations
Pharyngitis
|
2.3%
1/43
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43
|
|
Gastrointestinal disorders
Gastric ulcer
|
4.7%
2/43
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/43
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
1/43
|
|
Gastrointestinal disorders
Tongue disorder
|
2.3%
1/43
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43
|
|
Vascular disorders
Hypotension
|
9.3%
4/43
|
|
Vascular disorders
Hot flush
|
2.3%
1/43
|
|
Vascular disorders
Hypertension
|
2.3%
1/43
|
|
Vascular disorders
Orthostatic hypotension
|
2.3%
1/43
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
7.0%
3/43
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
2.3%
1/43
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.3%
1/43
|
|
General disorders
Asthenia
|
7.0%
3/43
|
|
General disorders
Chest discomfort
|
2.3%
1/43
|
|
Ear and labyrinth disorders
Vertigo
|
7.0%
3/43
|
|
Ear and labyrinth disorders
Deafness unilateral
|
2.3%
1/43
|
|
Eye disorders
Myopia
|
2.3%
1/43
|
|
Eye disorders
Visual disturbance
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Breast cyst
|
2.3%
1/43
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43
|
|
Cardiac disorders
Tachycardia
|
2.3%
1/43
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.3%
1/43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell granulomatosis
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/43
|
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