NCT01300364

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

February 21, 2011

Status Verified

November 1, 2008

Enrollment Period

3.1 years

First QC Date

February 18, 2011

Last Update Submit

February 18, 2011

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    24 weeks

Study Arms (3)

sugar pill

PLACEBO COMPARATOR
Drug: ReboxetineDrug: citalopram (SSRI)

reboxetine (NRI)

ACTIVE COMPARATOR
Drug: citalopram (SSRI)

citalopram (SSRI)

ACTIVE COMPARATOR
Drug: Reboxetine

Interventions

ReboxetineDRUG

8mg/day.

citalopram (SSRI)sugar pill
citalopram (SSRI)DRUG

30mg/day

reboxetine (NRI)sugar pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Sanitari Sant Joan de Déu

Sant Boi Llobregat, Barcelona, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25004184DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

ReboxetineCitalopramSelective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNeurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Central Study Contacts

Judith Usall U R, DRA.

CONTACT

936002650jusall@pssjd.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Last Updated

February 21, 2011

Record last verified: 2008-11

Locations

ES(1)