Treatment of Schizophrenic Patients With Ziprasidone (TRITON)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The use and dosage of ziprasidone for this Non-interventional Post-Marketing Surveillance study was based on the approved summary of product characteristics (SmPC) document and adjusted solely according to medical and therapeutic necessity.

Reporting Groups

	Description
Ziprasidone < 80 mg	Ziprasidone up to 80 milligrams (mg) per day.
Ziprasidone 80 mg to < 120 mg	Ziprasidone between 80 mg and < 120 mg per day.
Ziprasidone 120 mg to < 160 mg	Ziprasidone between 120 mg and < 160 mg per day.
Ziprasidone >= 160 mg	Ziprasidone 160 mg or greater per day.
Ziprasidone Unknown	Details are unknown.

Participant Flow:   Overall Study

	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
STARTED	15 [1]	57	88	285	5
Population: Within SmPC (Started)	15 [2]	56	83	159	0 [3]
Population: Within SmPC (Completed)	13 [4]	55 [5]	79 [6]	147 [7]	0
COMPLETED	13	56	84	263	5
NOT COMPLETED	2	1	4	22	0
Death	1	0	0	0	0
Adverse Event	1	0	1	2	0
Lack of Efficacy	0	0	1	14	0
Lost to Follow-up	0	1	0	4	0
Unknown	0	0	1	2	0
Withdrawal by Subject	0	0	1	0	0

Reporting Groups

	Description
Ziprasidone < 80 mg	Ziprasidone up to 80 milligrams (mg) per day.
Ziprasidone 80 mg to < 120 mg	Ziprasidone between 80 mg and < 120 mg per day.
Ziprasidone 120 mg to < 160 mg	Ziprasidone between 120 mg and < 160 mg per day.
Ziprasidone >= 160 mg	Ziprasidone 160 mg or greater per day.
Ziprasidone Unknown	Details are unknown.
Total	Total of all reporting groups

Baseline Measures

	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown	Total
Number of Participants   [units: participants]	15	57	88	285	5	450
Age, Customized   [units: Participants]
< 18 years	0	0	1	0	0	1
18 years through 44 years	3	22	42	169	2	238
45 years through 64 years	4	19	36	96	2	157
>= 65 years	8	16	9	20	1	54
Gender, Customized   [units: Participants]
Male	9	35	42	173	3	262
Female	6	22	45	110	2	185
Unspecified	0	0	1	2	0	3
Schizophrenia Duration   [units: Years] Mean ( Full Range )	33.9     ( 0 to 63.1 )	21.4     ( 0 to 58.5 )	16.9     ( 0 to 52.4 )	12.8     ( 0 to 50.3 )	15.6     ( 0 to 41.4 )	15.4     ( 0 to 63.1 )

1.  Primary:

Summary of Schizophrenia   [ Time Frame: Baseline ]

2.  Primary:

Summary of Metabolic Risk Factors   [ Time Frame: Baseline ]

3.  Primary:

Summary of Most Frequently Used Concomitant Drug Treatments   [ Time Frame: Baseline ]

4.  Secondary:

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)   [ Time Frame: Week 12 ]

5.  Secondary:

Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:

Positive and Negative Syndrome Scale (PANSS) - Positive Subscale   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:

PANSS - Negative Subscale   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:

PANSS - Composite Subscale   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"   [ Time Frame: Week 12 ]

10.  Secondary:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"   [ Time Frame: Week 12 ]

11.  Secondary:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"   [ Time Frame: Week 12 ]

12.  Secondary:

Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"   [ Time Frame: Week 12 ]

13.  Secondary:

Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"   [ Time Frame: Week 12 ]

14.  Secondary:

Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"   [ Time Frame: Week 12 ]

15.  Secondary:

Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"   [ Time Frame: Week 12 ]

16.  Secondary:

Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"   [ Time Frame: Week 12 ]

17.  Secondary:

Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"   [ Time Frame: Week 12 ]

18.  Secondary:

Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"   [ Time Frame: Week 12 ]

19.  Secondary:

Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"   [ Time Frame: Week 12 ]

20.  Secondary:

Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"   [ Time Frame: Week 12 ]

21.  Secondary:

Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"   [ Time Frame: Week 12 ]

22.  Secondary:

Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"   [ Time Frame: Week 12 ]

23.  Secondary:

Percent Change From Baseline to Final Visit in Body Weight   [ Time Frame: Baseline, Week 12 ]

24.  Other Pre-specified:

Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period   [ Time Frame: Week 12 ]

25.  Post-Hoc:

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)   [ Time Frame: Week 12 ]

26.  Post-Hoc:

Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC   [ Time Frame: Baseline, Week 12 ]

27.  Post-Hoc:

Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC   [ Time Frame: Baseline, Week 12 ]

28.  Post-Hoc:

PANSS - Negative Subscale: Within SmPC   [ Time Frame: Baseline, Week 12 ]

29.  Post-Hoc:

PANSS - Composite Subscale: Within SmPC   [ Time Frame: Baseline, Week 12 ]

30.  Post-Hoc:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?": Within SmPC   [ Time Frame: Week 12 ]

31.  Post-Hoc:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?": Within SmPC   [ Time Frame: Week 12 ]

32.  Post-Hoc:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?": Within SmPC   [ Time Frame: Week 12 ]

33.  Post-Hoc:

Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?": Within SmPC   [ Time Frame: Week 12 ]

34.  Post-Hoc:

Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?": Within SmPC   [ Time Frame: Week 12 ]

35.  Post-Hoc:

Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?": Within SmPC   [ Time Frame: Week 12 ]

36.  Post-Hoc:

Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?": Within SmPC   [ Time Frame: Week 12 ]

37.  Post-Hoc:

Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?": Within SmPC   [ Time Frame: Week 12 ]

38.  Post-Hoc:

Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?": Within SmPC   [ Time Frame: Week 12 ]

39.  Post-Hoc:

Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?": Within SmPC   [ Time Frame: Week 12 ]

40.  Post-Hoc:

Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?": Within SmPC   [ Time Frame: Week 12 ]

41.  Post-Hoc:

Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?": Within SmPC   [ Time Frame: Week 12 ]

42.  Post-Hoc:

Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?": Within SmPC   [ Time Frame: Week 12 ]

43.  Post-Hoc:

Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?": Within SmPC   [ Time Frame: Week 12 ]

44.  Post-Hoc:

Percent Change From Baseline to Final Visit in Body Weight: Within SmPC   [ Time Frame: Baseline, Week 12 ]

45.  Post-Hoc:

Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC   [ Time Frame: Week 12 ]