The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores.NCT01260116
Efficacy and Safety of Ziprasidone to Treat Depressive Symptoms in Patients With Schizophrenia
An observational study of The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores. and The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales., run by Wuhan University.
Trial summary
This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental centers in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores., The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales., Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc.
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia company with depressive symptoms
Who may be able to join
- (1).First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia and a minimum score of 70 on the Positive and Negative Syndrome Scale (PANSS) at randomization. First-episode is defined as duration of illness from the onset of psychotic symptoms ranged from 3 days to 36 months and without systemic treatment. Refractory is defined as failure to experience a therapeutic response during acute exacerbation following adequate trials of marketed antipsychotic agents on two or more occasions during the two years prior to study entry.
- (2).Patients who meet DSM-IV-TR criteria for schizophrenia and have been diagnosed as having "295.XX schizophrenia".
- (3).Patients with a CDSS total score of 5 or more in screening visit and baseline visit.
- (4).Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Who cannot join
- (1).Patients who have received systemic treatment of any antipsychotics or antidepressants within 12 weeks prior to informed consent.
- (2).Women who are pregnant, possibly pregnant, or breast-feeding. (3).Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance.
- (4).Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders but including abuse of benzodiazepines) (5).Patients who have received ECT treatment within 8 weeks prior to informed Consent.
- (6).Patients who have used supplements containing centrally-acting substances (tryptophan, St. John's wort) within 4 weeks prior to informed consent.
- (7).Patients with unstable thyroid disorder (hypothyroidism, hyperthyroidism) or those who have received thyroid treatment within 3 months (90 days) prior to informed consent.
- (8).Patients considered to be unresponsive to clozapine (9).Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the study, or who have a history of such a condition. For example, patients diagnosed as having a complication of serious hepatic, renal, cardiac, or hematopoietic disorder, such as those described below, within 4 weeks prior to informed consent or during the screening period Hepatic disorder: Total bilirubin≥3.0 mg/dL, AST (GOT) and ALT(GPT)≥2.5 times the upper limits of normal levels Renal disorder: Creatinine ≥ 2 mg/dL Cardiac disorder: patients with a known history of QT prolongation (including congenital long QT syndrome); patients with recent acute myocardial infarction; patients with uncompensated heart failure (10).Patients known to have a history or complication of allergy to ziprasidone or other quinolinone-skeleton compounds (11).Patients with a history or a complication of neuroleptic malignant syndrome (12).Patients who represent a significant risk of committing suicide (13).Patients with a history or a complication of organic brain disorder or convulsive disorder, such as epilepsy
About this study
Official title: Efficacy and Safety of Ziprasidone in the Treatment of Depressive Symptoms in Patients With Schizophrenia：an 8-week Open-label Study
This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental centers in China. Subjects will be required to attend the center at screening, baseline, Weeks 1, 2, 4 ,6 and 8 or early termination visit.
At screening, patients underwent psychiatric and physical examination, standard lab tests, and an Electrocardiograph.
At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.
Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum of 80 mg twice daily.
Read the detailed description
Primary objective The primary objective was to evaluate the efficacy of ziprasidone in the treatment of depressive symptoms in patients with schizophrenia.
Secondary objectives The secondary objective was to evaluate the efficacy and the safety and tolerability of ziprasidone in the treatment of schizophrenic patients with depressive symptoms.
Study design This study was going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study was carried out at 2 mental centers in China. Subjects were required to attend the center at screening, baseline, Weeks 1, 2, 4 ,6 and 8 or early termination visit.
At screening, patients underwent psychiatric and physical examination, standard lab tests, and an Electrocardiograph.
At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.
Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum of 80 mg twice daily.
Dosage/Administration
At baseline subjects received study drug according to the following regimen:
Day 1-2: ziprasidone 20 mg twice daily. Day 3-4: ziprasidone 40 mg twice daily. Day 5-6: ziprasidone 60 mg twice daily. Day 7-Week 8: ziprasidone 40, 60 or 80 mg twice daily. At visit 3 (week 1) the dosage of study drug was titrated up or down based on the clinical status of the subject and the safety and tolerability of the study drug. Subjects received all study drugs with food and under supervision.
Treatment Duration It's a 8 weeks' study. There are 7 visits in this study. Visit 1 is screening visit; Visit 2 is baseline visit; Visit 3 is Week 1; Visit 4 is Week 2; Visit 5 is Week 4; Visit 6 is Week 6; Visit 7 is Week 8.
- Conditions
- The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores., The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales., Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc., Subjective Well-being Under Neuroleptics Short Form Will be Used in Our Study to Assess the Subjective Side-effects.
- Keywords
- Efficacy,safety,ziprasidone,depressive symptoms ,schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Ziprasidone,Zeldox capsule |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260116
- Sponsor's protocol ID
- WS897429
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ziprasidone in the Treatment of Depressive Symptoms in Patients With Schizophrenia：an 8-week Open-label Study
- ClinicalTrials.gov ID
- NCT01260116
- Acronym / sponsor ID
- WS897429
- Conditions
- The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores., The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales., Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc., Subjective Well-being Under Neuroleptics Short Form Will be Used in Our Study to Assess the Subjective Side-effects.
- Keywords
- Efficacy,safety,ziprasidone,depressive symptoms ,schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Collaborators
- Peking University, Pfizer
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental centers in China. Subjects will be required to attend the center at screening, baseline, Weeks 1, 2, 4 ,6 and 8 or early termination visit.
At screening, patients underwent psychiatric and physical examination, standard lab tests, and an Electrocardiograph.
At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.
Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum of 80 mg twice daily.
Detailed description
Primary objective The primary objective was to evaluate the efficacy of ziprasidone in the treatment of depressive symptoms in patients with schizophrenia.
Secondary objectives The secondary objective was to evaluate the efficacy and the safety and tolerability of ziprasidone in the treatment of schizophrenic patients with depressive symptoms.
Study design This study was going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study was carried out at 2 mental centers in China. Subjects were required to attend the center at screening, baseline, Weeks 1, 2, 4 ,6 and 8 or early termination visit.
At screening, patients underwent psychiatric and physical examination, standard lab tests, and an Electrocardiograph.
At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.
Depending on response and tolerability, ziprasidone could be gradually escalated to a maximum of 80 mg twice daily.
Dosage/Administration
At baseline subjects received study drug according to the following regimen:
Day 1-2: ziprasidone 20 mg twice daily. Day 3-4: ziprasidone 40 mg twice daily. Day 5-6: ziprasidone 60 mg twice daily. Day 7-Week 8: ziprasidone 40, 60 or 80 mg twice daily. At visit 3 (week 1) the dosage of study drug was titrated up or down based on the clinical status of the subject and the safety and tolerability of the study drug. Subjects received all study drugs with food and under supervision.
Treatment Duration It's a 8 weeks' study. There are 7 visits in this study. Visit 1 is screening visit; Visit 2 is baseline visit; Visit 3 is Week 1; Visit 4 is Week 2; Visit 5 is Week 4; Visit 6 is Week 6; Visit 7 is Week 8.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Ziprasidone,Zeldox capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia company with depressive symptoms
Key inclusion criteria (4 listed)
- (1).First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia and a minimum score of 70 on the Positive and Negative Syndrome Scale (PANSS) at randomization. First-episode is defined as duration of illness from the onset of psychotic symptoms ranged from 3 days to 36 months and without systemic treatment. Refractory is defined as failure to experience a therapeutic response during acute exacerbation following adequate trials of marketed antipsychotic agents on two or more occasions during the two years prior to study entry.
- (2).Patients who meet DSM-IV-TR criteria for schizophrenia and have been diagnosed as having "295.XX schizophrenia".
- (3).Patients with a CDSS total score of 5 or more in screening visit and baseline visit.
- (4).Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Key exclusion criteria (6 listed)
- (1).Patients who have received systemic treatment of any antipsychotics or antidepressants within 12 weeks prior to informed consent.
- (2).Women who are pregnant, possibly pregnant, or breast-feeding. (3).Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance.
- (4).Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders but including abuse of benzodiazepines) (5).Patients who have received ECT treatment within 8 weeks prior to informed Consent.
- (6).Patients who have used supplements containing centrally-acting substances (tryptophan, St. John's wort) within 4 weeks prior to informed consent.
- (7).Patients with unstable thyroid disorder (hypothyroidism, hyperthyroidism) or those who have received thyroid treatment within 3 months (90 days) prior to informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores. and The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales., run by Wuhan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.