ICD-10 diagnosis F32.3
Conditions
Interventions
Trade Name: Cipralex
Product Name: Cipralex
Pharmaceutical Form: Tablet
INN or Proposed INN: ESCITALOPRAM
Trade Name: Risperdal
Product Name: Risperdal
Pharmaceutical Form: Tablet
INN or Proposed INN
Sponsors
Turku university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) ICD-10 diagnosis F32.3 or F33.3; (2) informed consent; (3) age no less than 18 years; (4) psychotic patient (operationally defined in this trial as a score of > 2 from at least three items of the BPRS-PSYK subscale (Taiminen et al. 2000) and/or a score of > 4 from BPRS Scale item 5 “Guilt”). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) patient on antipsychotic medication or on other antidepressant than escitalopram, and the patient or his/her physician is not willing to interrupt the medication for the two-week wash-out period; (2) history of continuous depressive and/or psychotic symptoms for more than 6 months before the beginning of the trial; (3) somatic disease that is unstable or causes an immediate risk (chronic somatic disease under control, such as diabetes, is not a contraindication to inclusion); (4) the responsible physician believes that the patient will probably benefit from ECT, and the patient is willing to undergo such treatment; (5) the physician considers that due to his/her psychotic symptoms the patient is not capable of understanding the contents of the trial and/or the meaning of informed consent; (6) intoxicant and/or drug dependence that is not in remission or has been in remission for < 6 months; (7) contraindication listed in the most recent Pharmaca Fennica for either escitalopram or risperidone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present trial is to compare the efficacy of escitalopram monotherapy and a combination of escitalopram and risperidone in the treatment of psychotic depression. ;Secondary Objective: Secondary endpoints are mean time to remission from psychosis (in the trial a patient is defined as being psychotic if he/she receives a score of > 2 in at least three items of the BPRS-PSYK subscalechange in the severity of depressive symptoms from the beginning of the trial to week 8 as measured on the MADRS scale and change in the severity of delusions from the beginning of the trial to week 8 as measured on the BABS scale ;Primary end point(s): The primary endpoint is the change in psychotic symptoms from the beginning of the trial to week 8 as measured by the psychotic disorganisation subscore (BPRS-PSYK) on the BPRS scale (Brief Psychiatric Rating Scale, Bech 1993) and, additionally, the score from BPRS item 5 “Guilt”. Secondary endpoints are mean time to remission from psychosis (in the trial a patient is defined as being psychotic if he/she receives a score of > 2 in at least three items of the BPRS-PSYK subscale (Taiminen et al. 2000) and/or a score of > 4 from the BPRS item 5 “Guilt”); change in the severity of depressive symptoms from the beginning of the trial to week 8 as measured on the MADRS scale (Montgomery-Åsberg Depression Rating Scale, Bech 1993); and change in the severity of delusions from the beginning of the trial to week 8 as measured on the BABS scale (Brown Assessment of Beliefs Scale, Eisen et al. 1998). | — |
Countries
Finland
Outcome results
None listed