Negative and depressive symptoms of schizophrenia according to DSM-5
Conditions
Interventions
Trade Name: Ketanest S 25 mg/ml (2 ml) Ampullen
Product Name: Ketanest S 25 mg/ml (2 ml) Ampullen
Product Code: 1–22525
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: ESKETA
Sponsors
Medizinische Universität Wien, Universitätsklinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of schizophrenia, other non-affective psychotic disorder, or schizoaffective disorder according to DSM-5 • Minimum score of 60 on the Scale for the Assessment of Negative Symptoms (SANS; Andreasen 1989) or • Minimum score of 22 on the Montgomery and Åsberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) • Age of at least 18 years • Ability to provide written informed consent • Female patients of childbearing potential need to utilize a proper method of contraception (pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm) 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results • Clinically relevant abnormalities in the electro-cardiogram (ECG) • History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states • Untreated or unstable arterial hypertension • Established diagnosis of advanced arteriosclerosis or hyperthyroidism • Intolerance to Ketanest® or Dibondrin® • Pregnancy or lactation • Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine) • Acute suicidal or homicidal ideation • Presence of ferromagnetic metal in the body or heart pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that treatment with esketamine is superior over placebo in ameliorating negative and depressive symptoms in patients with schizophrenia, schizophreniform disorder or schizoaffective disorder;Secondary Objective: To investigate effects of esketamine treatment on positive symptoms of schizophrenia, schizophreniform disorder or schizoaffective disorder for supporting the claim that esketamine will not lead to psychotic exacerbation in these patients;Primary end point(s): •Change in the Scale for the Assessment of Negative Symptoms (SANS; Andreasen 1982) •Change in Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery & Asberg 1979);Timepoint(s) of evaluation of this end point: •Before initiation of treatment with study drug period 1 (KET/PLC; baseline study period 1) •Six times during treatment with study drug period 1 (KET/PLC; study week 1-2) •Before initiation of treatment with study drug period 2 (KET/PLC; baseline study period 2; study week 4) •Six times during treatment with study drug period 2 (KET/PLC; study week 5-6) •One and two weeks after end of study related treatment (study week 7 and 8) 6 times week 4-5, once week 6, once week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in Positive and Negative Syndrome Scale (PANSS; Kay et al. 1987) • Change in Calgary Depression Rating Scale for Schizophrenia (CDSS; Addington et al. 1992) • Clinical Global Impression Scale (CGI; Guy 1976) • Clinician Administered Dissociative States Scale (CADSS; Addinbgton et al. 1992) ;Timepoint(s) of evaluation of this end point: • Before initiation of treatment with study drug period 1 (KET/PLC; baseline study period 1) • Six times during treatment with study drug period 1 (KET/PLC; study week 1-2) • Before initiation of treatment with study drug period 2 (KET/PLC; baseline study period 2; study week 4) • Six times during treatment with study drug period 2 (KET/PLC; study week 5-6) • One and two weeks after end of study related treatment (study week 7 and 8) | — |
Countries
Austria
Contacts
Public ContactUniversitätsklinik für Psychiatrie
Medizinische Universität Wien
Outcome results
None listed