E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ICD-10 diagnosis F32.3; psykoottinen masennus, F 33.3; toistuva psykoottinen masennus. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012392 |
E.1.2 | Term | Depression psychic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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”). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |