SchizophreniaPhase 3NCT00148447
The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia
A Phase 3 study testing escitalopram in people with Schizophrenia, run by BeerYaakov Mental Health Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- escitalopram
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2004to Sep 2005
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic schizophrenia patients,
- Age <60,
- Medicated,
- Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
- Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
- A Positive and Negative Syndrome Scale (PANSS) score of 50 or above will be required for entry to the study.
Who cannot join
- Comorbidity with mania or major depression,
- Pregnancy,
- Lactation,
- Impaired renal or hepatic function,
- History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
- Additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and CGI scores of "condition much worsened".
- Patients will be excluded during the study if they will remove their informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.
Read the detailed description
The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study. As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible. However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e. antipsychotic medication).
- Conditions
- Schizophrenia
- Being tested
- escitalopram
- Keywords
- negative symptoms, depression, ssri, schizophrenia
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
negative symptoms
social function
Secondary outcomes (3)
positive symptoms
Clinical Global Impression (CGI)
depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startNov 2004
- Study completionSep 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Lundbeck Israel
- Investigators
- Iulian Iancu, M.D., Principal investigator, Beer Yaakov Mental Health CenterMoshe Kotler, M.D., Study chair, Beer Yaakov Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148447
- Sponsor's protocol ID
- Escitalopram-118CTIL
- Status last verified
- Feb 2007
- First submitted
- 6 Sep 2005
- Last updated
- 3 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedman JI, Ocampo R, Elbaz Z, Parrella M, White L, Bowler S, Davis KL, Harvey PD. The effect of citalopram adjunctive treatment added to atypical antipsychotic medications for cognitive performance in patients with schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):237-42. doi: 10.1097/01.jcp.0000161499.58266.51.
PubMed 15876902
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT00148447
- Acronym / sponsor ID
- Escitalopram-118CTIL
- Conditions
- Schizophrenia
- Keywords
- negative symptoms, depression, ssri, schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Collaborators
- Lundbeck Israel
- Study start
- Nov 2004
- Study completion
- Sep 2005
- First posted
- 8 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.
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.
Detailed description
The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study. As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible. However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e. antipsychotic medication).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chronic schizophrenia patients,
- Age <60,
- Medicated,
- Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
- Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
Key exclusion criteria (7 listed)
- Comorbidity with mania or major depression,
- Pregnancy,
- Lactation,
- Impaired renal or hepatic function,
- History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
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 |
|---|---|---|
| escitalopram | Drug | – |
Primary outcome
negative symptoms
social function
3 secondary outcomes
positive symptoms
Clinical Global Impression (CGI)
depression
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 3 May 2007.
- Background: PubMed 15876902Friedman JI, Ocampo R, Elbaz Z, Parrella M, White L, Bowler S, Davis KL, Harvey PD. The effect of citalopram adjunctive treatment added to atypical antipsychotic medications for cognitive performance in patients with schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):237-42. doi: 10.1097/01.jcp.0000161499.58266.51.
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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.
Iulian Iancu, M.D. principal investigator
Beer Yaakov Mental Health Center
Moshe Kotler, M.D. study chair
Beer Yaakov Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing escitalopram in people with Schizophrenia, run by BeerYaakov Mental Health 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 6 inclusion and 7 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 3 May 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
negative symptoms. The study lists 2 primary outcomes in all. 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 NCT00148447, 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 3 May 2007.