SchizophreniaNCT00229385
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
A study testing Ziprasidone in people with Schizophrenia and Obsessive Compulsive Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Obsessive Compulsive Disorder
- What is being tested?
- Ziprasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Apr 2010
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of Schizophrenia and OCD for at least 6 months
- Minimum score of 14 on YBOCS
- Minimum score of 60 on PANSS
- Diagnosis of Schizophrenia without OC symptoms
Who cannot join
- Patients who are already being treated with ziprasidone
- Diagnosis of schizophreniform disorder
- Organic brain syndrome, mental retardation and pervasive developmental disorder
- Patients having any significantly cardiovascular illness or electrolyte imbalance
Trial locations and contacts
1 site in 1 country.
About this study
Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients
- Conditions
- Schizophrenia, Obsessive Compulsive Disorder
- Being tested
- Ziprasidone
- Medical subject headings
- Schizophrenia, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
40-80 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Ziprasidone |
| 2 | Active comparator | Not described Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Joseph Zohar, Sheba Medical Center
- Investigators
- Joseph Zohar, MD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229385
- Sponsor's protocol ID
- SHEBA-03-3061-JS-CTIL
- Status last verified
- Dec 2013
- First submitted
- 28 Sep 2005
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT00229385
- Acronym / sponsor ID
- SHEBA-03-3061-JS-CTIL
- Conditions
- Schizophrenia, Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Sep 2005 (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.
Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in response to Ziprasidone and in cognitive functioning as compared with OCD patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ziprasidone |
| 2 | Active comparator | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Schizophrenia and OCD for at least 6 months
- Minimum score of 14 on YBOCS
- Minimum score of 60 on PANSS
- Diagnosis of Schizophrenia without OC symptoms
Key exclusion criteria (4 listed)
- Patients who are already being treated with ziprasidone
- Diagnosis of schizophreniform disorder
- Organic brain syndrome, mental retardation and pervasive developmental disorder
- Patients having any significantly cardiovascular illness or electrolyte imbalance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziprasidone40-80 mg BID | Drug | 1, 2 |
Primary outcome
YBOCS
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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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.
Joseph Zohar, MD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ziprasidone in people with Schizophrenia and Obsessive Compulsive Disorder, run by Sheba Medical Center at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
YBOCS (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
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 31 Dec 2013.