SchizophreniaPhase 4NCT01300364
Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
A Phase 4 study testing Reboxetine and citalopram (SSRI) in people with Schizophrenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of… 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 and citalopram (SSRI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Dec 2011
- Phase
- Phase 4
- 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 (DSM-IV criteria)
- Stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
- Presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the PANSS scale) (Kay 1987)
- Patients have to give written informed consent to participate in the study
Who cannot join
- Patients with a substance abuse/dependence diagnosis in the previous six months.
- Mental Retardation.
- Patients taking antidepressant in the last 4 months before the trial.
- Patients taking other antipsychotic medication, except: sinquan 100, Entumine 40, Largactil 100 and Seroquel 200.
- Patients who score more than 20 in Hamilton Rating Scale for Depression.
- Pregnancy or lactation.
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- Serious impaired kidney function.
- History of hemorrhagic disorders.
- Reboxetine or citalopram allergy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi Llobregat, Barcelona
Judith Usall, 93 6002650 ext. 2356, jusall@pssjd.org
About this study
Official title: Double-blind Clinical Trial Controlled With Placebo of the Efficacy of Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia.
Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia.
Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria) and significant negative symptoms, will be recruited in the 9 participating centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP, Hamilton scale, BACS)
- Conditions
- Schizophrenia
- Being tested
- Reboxetine, citalopram (SSRI)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReboxetineDrug
8mg/day.
citalopram (SSRI)Drug
30mg/day
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Not described Receives: Drug: Reboxetine; Drug: citalopram (SSRI) |
| reboxetine (NRI) | Active comparator | Not described Receives: Drug: citalopram (SSRI) |
| citalopram (SSRI) | Active comparator | Not described Receives: Drug: Reboxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
Measured: 24 weeks
Secondary outcomes (1)
Secondary efficacy endpoints will be the change in the scores of the total PANSS and all the other clinical, social and neuropsychological scales from baseline to follow-up evaluation.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startNov 2008
- Primary completionDec 2011 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300364
- Sponsor's protocol ID
- EC07/90093
- Status last verified
- Nov 2008
- First submitted
- 18 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Usall J, Lopez-Carrilero R, Iniesta R, Roca M, Caballero M, Rodriguez-Jimenez R, Oliveira C, Bernardo M, Corripio I, Sindreu SD, Gonzalez Piqueras JC, Felipe AE, Fernandez de Corres B, Ibanez A, Huerta R; Abordaje Sintomas Negativos Esquizofrenia Group. Double-blind, placebo-controlled study of the efficacy of reboxetine and citalopram as adjuncts to atypical antipsychotics for negative symptoms of schizophrenia. J Clin Psychiatry. 2014 Jun;75(6):608-15. doi: 10.4088/JCP.13m08551.
PubMed 25004184
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Clinical Trial Controlled With Placebo of the Efficacy of Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT01300364
- Acronym / sponsor ID
- EC07/90093
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (estimated)
- First posted
- 21 Feb 2011 (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.
Main objective: To assess the efficacy of two antidepressants of different pharmacological families: citalopram (Selective serotonin reuptake inhibitors, SSRI) and reboxetine (Norepinephrine Reuptake inhibitor, NRI) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia.
Secondary objectives: To assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. To compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia.
Method: Multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. A total of 249 patients with a diagnosis of schizophrenia (DSM-IV criteria) and significant negative symptoms, will be recruited in the 9 participating centres. Variables: sociodemographic and clinical variables (PANSS, SANS, CGI global, GAF,LSP, Hamilton scale, BACS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: Reboxetine, Drug: citalopram (SSRI) |
| reboxetine (NRI) | Active comparator | Drug: citalopram (SSRI) |
| citalopram (SSRI) | Active comparator | Drug: Reboxetine |
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 (DSM-IV criteria)
- Stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation
- Presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the PANSS scale) (Kay 1987)
- Patients have to give written informed consent to participate in the study
Key exclusion criteria (9 listed)
- Patients with a substance abuse/dependence diagnosis in the previous six months.
- Mental Retardation.
- Patients taking antidepressant in the last 4 months before the trial.
- Patients taking other antipsychotic medication, except: sinquan 100, Entumine 40, Largactil 100 and Seroquel 200.
- Patients who score more than 20 in Hamilton Rating Scale for Depression.
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 |
|---|---|---|
| Reboxetine8mg/day. | Drug | citalopram (SSRI), sugar pill |
| citalopram (SSRI)30mg/day | Drug | reboxetine (NRI), sugar pill |
Primary outcome
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
Time frame: 24 weeks
1 secondary outcome
Secondary efficacy endpoints will be the change in the scores of the total PANSS and all the other clinical, social and neuropsychological scales from baseline to follow-up evaluation.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Derived from this study: PubMed 25004184Usall J, Lopez-Carrilero R, Iniesta R, Roca M, Caballero M, Rodriguez-Jimenez R, Oliveira C, Bernardo M, Corripio I, Sindreu SD, Gonzalez Piqueras JC, Felipe AE, Fernandez de Corres B, Ibanez A, Huerta R; Abordaje Sintomas Negativos Esquizofrenia Group. Double-blind, placebo-controlled study of the efficacy of reboxetine and citalopram as adjuncts to atypical antipsychotics for negative symptoms of schizophrenia. J Clin Psychiatry. 2014 Jun;75(6):608-15. doi: 10.4088/JCP.13m08551.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reboxetine and citalopram (SSRI) in people with Schizophrenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 9 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 21 Feb 2011. 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 Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Judith Usall U R, DRA. (936002650 ext. 2356, jusall@pssjd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment. (time frame: 24 weeks). 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 NCT01300364, 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 21 Feb 2011.