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Please see Brief Summary for Termination Reason.
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The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone hydrochloride | Drug | Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase. | up to 10 weeks | |
| Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aachen | 52074 | Germany | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine.
47 centers in Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Olanzapine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| olanzapine | Drug | Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day. |
|
| 6 months |
| Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase. | 4, 6 and 10 weeks |
| Time to Symptomatic Remission in the Double Blind Phase. | up to 10 weeks |
| Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment. | 6 weeks |
| Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. | 6 months |
| Augsburg |
| 86156 |
| Germany |
| Pfizer Investigational Site | Freiburg im Breisgau | 79104 | Germany |
| Pfizer Investigational Site | Athens | 124 62 | Greece |
| Pfizer Investigational Site | S. Arsenio | Salerno | 84037 | Italy |
| Pfizer Investigational Site | Bari | 70100 | Italy |
| Pfizer Investigational Site | Guardiagrele (CH) | 66016 | Italy |
| Pfizer Investigational Site | Lido Di Camaiore (LU) | 55043 | Italy |
| Pfizer Investigational Site | Partinico (Pa) | 90047 | Italy |
| Pfizer Investigational Site | Perugia | 06127 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| Pfizer Investigational Site | Trieste | 34126 | Italy |
| Pfizer Investigational Site | Terrassa | Barcelona | 08227 | Spain |
| Pfizer Investigational Site | Alava | Vitoria | 01004 | Spain |
| Pfizer Investigational Site | Granada | 18014 | Spain |
| Pfizer Investigational Site | Málaga | 29009 | Spain |
| Pfizer Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | 34440 | Turkey (Türkiye) |
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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. | 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. | Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized. | Posted | 4 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase. | Not Posted | up to 10 weeks | Participants | |||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase. | Not Posted | 6 months | Participants | |||||||||||||||||||||||||
| Secondary | Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase. | Not Posted | 4, 6 and 10 weeks | Participants | |||||||||||||||||||||||||
| Secondary | Time to Symptomatic Remission in the Double Blind Phase. | Not Posted | up to 10 weeks | Participants | |||||||||||||||||||||||||
| Secondary | Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment. | Not Posted | 6 weeks | Participants | |||||||||||||||||||||||||
| Secondary | Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. | Not Posted | 6 months | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 7 | ||||
| EG001 | 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. | 0 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oculogyric crisis | Eye disorders | MedRA v11.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedRA v11.1 | Systematic Assessment |
| |
| laryngospasm | Respiratory, thoracic and mediastinal disorders | MedRA v11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| Hyperprolactinaemia | Endocrine disorders | MedDRA v11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
| |
| flatulence | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
| |
| gingivitis | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA v11.1 | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA v11.1 | Systematic Assessment |
| |
| hypersensitivity | Immune system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA v11.1 | Systematic Assessment |
| |
| pneumonia bacterial | Infections and infestations | MedDRA v11.1 | Systematic Assessment |
| |
| tonsillitis | Infections and infestations | MedDRA v11.1 | Systematic Assessment |
| |
| joint dislocation | Injury, poisoning and procedural complications | MedDRA v11.1 | Systematic Assessment |
| |
| weight increased | Investigations | MedDRA v11.1 | Systematic Assessment |
| |
| fluid retention | Metabolism and nutrition disorders | MedDRA v11.1 | Systematic Assessment |
| |
| hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v11.1 | Systematic Assessment |
| |
| increased appetite | Metabolism and nutrition disorders | MedDRA v11.1 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| hypotonia | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| tremor | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| binge eating | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| delusion | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| depressed mood | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| mania | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
| |
| breast enlargement | Reproductive system and breast disorders | MedDRA v11.1 | Systematic Assessment |
| |
| sexual dysfunction | Reproductive system and breast disorders | MedDRA v11.1 | Systematic Assessment |
| |
| eczema | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Systematic Assessment |
| |
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Systematic Assessment |
| |
| tooth extraction | Surgical and medical procedures | MedDRA v11.1 | Systematic Assessment |
|
The study was terminated due to poor recruitment. No efficacy data were summarized due to very low sample size. Only safety data were summarized.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| Male |
|