Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01300364

Enrollment

249

Registered

2011-02-21

Start date

2008-11-30

Completion date

Unknown

Last updated

2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief 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 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)

Interventions

DRUGReboxetine

8mg/day.

DRUGcitalopram (SSRI)

30mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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. * Serious impaired kidney function. * History of hemorrhagic disorders. * Reboxetine or citalopram allergy.

Design outcomes

Primary

Measure	Time frame
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.	24 weeks

Secondary

Measure	Time frame
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.	24 weeks

Countries

Spain

Contacts

Primary ContactJudith Usall U R, DRA.

jusall@pssjd.org936002650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026