SchizophreniaPhase 1NCT00409201
Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia
A Phase 1 study testing reboxetine adjuvant therapy in people with Schizophrenia, run by Abarbanel Mental Health Center at 2 sites in Israel.
Trial summary
30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- reboxetine adjuvant therapy
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2006to Nov 2006
- Phase
- Phase 1
- 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
- schizophrenia all types
- 18>
Who cannot join
- uti
- >65
- non organic state
- no depression treatment
Trial locations and contacts
2 sites in 1 country.
stanislav baranchik, md contact
Israel2 sites, 2 recruiting
- Recruiting
Abarbanel Medical Mental Health Center
Bat Yam, 59100
stanislav baranchik, md, 972-3-5552625
alex aviv, md, 972-3-552703, alexaviv@gmail.com
- Recruiting
Abarbanel Medical Mental Health Center
Bat Yam, 59100
stanislav baranchik, md
About this study
Official title: Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures
30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.
Read the detailed description
all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg * 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. * 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.
- Conditions
- Schizophrenia
- Being tested
- reboxetine adjuvant therapy
- Keywords
- schizophrenia, reboxetine, cognitive, behavior
- Medical subject headings
- Schizophrenia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reboxetine adjuvant therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test
Secondary outcomes (1)
esrs, progesterom, sexual functioning, covy, cgi, cgi improved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startMar 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Abarbanel Mental Health Center
- Sponsor type
- Other government
- Investigators
- stanislav baranchik, md, Principal investigator, abarbanel mhc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409201
- Sponsor's protocol ID
- 284
- Status last verified
- Mar 2006
- First submitted
- 7 Dec 2006
- Last updated
- 8 Dec 2006
- Results posted
- No
Publications
Schutz G, Berk M. Reboxetine add on therapy to haloperidol in the treatment of schizophrenia: a preliminary double-blind randomized placebo-controlled study. Int Clin Psychopharmacol. 2001 Sep;16(5):275-8. doi: 10.1097/00004850-200109000-00004.
PubMed 11552770
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures
- ClinicalTrials.gov ID
- NCT00409201
- Acronym / sponsor ID
- 284
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, reboxetine, cognitive, behavior
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Abarbanel Mental Health CenterOther government
- Study start
- Mar 2006
- Study completion
- Nov 2006
- First posted
- 8 Dec 2006 (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.
30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.
Detailed description
all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg * 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. * 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- schizophrenia all types
- 18>
Key exclusion criteria (4 listed)
- uti
- >65
- non organic state
- no depression treatment
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 |
|---|---|---|
| reboxetine adjuvant therapy | Drug | – |
Primary outcome
sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test
1 secondary outcome
esrs, progesterom, sexual functioning, covy, cgi, cgi improved
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2006.
- Background: PubMed 11552770Schutz G, Berk M. Reboxetine add on therapy to haloperidol in the treatment of schizophrenia: a preliminary double-blind randomized placebo-controlled study. Int Clin Psychopharmacol. 2001 Sep;16(5):275-8. doi: 10.1097/00004850-200109000-00004.
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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.
stanislav baranchik, md contact
stanislav baranchik, md principal investigator
abarbanel mhc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing reboxetine adjuvant therapy in people with Schizophrenia, run by Abarbanel Mental Health Center at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 8 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact stanislav baranchik, md (972-3-5552625), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409201, which also lists 1 linked publication.
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 8 Dec 2006.