Brain activation by addition of L-Dopa to normal antipsychotic treatment in patients with schizophrenia

Selective D1 activation by addition of L-Dopa to antipsychotic treatment in patients with schizophrenia - ALOHA

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019897-33-NL

Enrollment

Registered

2010-08-09

Start date

2011-04-14

Completion date

Unknown

Last updated

2024-04-08

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

Conditions

patients with psychotic symptoms, diagnosed with schizophrenia

Interventions

Trade Name: Sinemet Product Name: Sinemet Pharmaceutical Form: Tablet INN or Proposed INN: LEVODOPA CAS Number: 59-92-7 Other descriptive name: L-dopa Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients will be recruited from the Psychiatry ward of the Erasmus Medical Center, Rotterdam, and diagnosed according to DSM-IV criteria by a senior psychiatrist Patients will be included if they meet the criteria for schizophrenia. Further inclusion criteria inpatients aged 18-40 years with a diagnosis of schizophrenia, stable under haloperidol or risperidone treatment (=20 points, or >3 points on no more than three items on PANSS positive symptom scale), with significant negative symptoms (total of >20 points, or >3 points on two items on PANSS negative symptom scale) are eligible for the study. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnancy,use of psychotropic medication other than benzodiazepines serious neurological disorders. Subjects will also be excluded when they cannot understand Dutch language sufficiently to understand the purposes and implications of the experiment.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To study whether cognitive functions in patients with schizophrenia are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment 2. To study whether negative psychotic symptoms are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment;Secondary Objective: 3. To study whether positive psychotic symptoms will be affected by L-dopa addition to optimized conventional (D2-blocking) antipsychotic treatment? 4. To study whether extrapyramidal symptoms, as frequently seen in patients with schizophrenia who are treated with conventional (D2-blocking) antipsychotic treatment, are reduced by addition of L-dopa.;Primary end point(s): There will be three primary outcome measures. The first primary outcome measure is the change in verbal memory, as compared between patients receiving placebo vs those receiving L-Dopa. Verbal memory is assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R), which is included in the MATRICS. Earlier studies have reported a great difference in verbal memory function between patients with schizophrenia and healthy controls (e.g. Cascella et al., 2008). We expect L-dopa addition will lead to an improvement of verbal memory function of at least 25% towards the level of healthy control subjects. Based on the effect size found in earlier studies comparing patients with schizophrenia with healthy controls (Cascella et al., 2008), a power analysis indicates we would need to include approximately 40 patients in order to reliably show a 25% increase in verbal memory function. The second primary outcome measure is the alteration in working memory as assessed by the N-Back, task as compared between patients receiving placebo vs those receiving L-Dopa. Earlier studies have shown a significant difference in accuracy and reaction time in a 2-back task, between patients with schizophrenia and healthy controls (Schneider et al., 2007; Karch et al, 2009). By ad	—

Measure

Time frame

Main Objective: 1. To study whether cognitive functions in patients with schizophrenia are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment 2. To study whether negative psychotic symptoms are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment;Secondary Objective: 3. To study whether positive psychotic symptoms will be affected by L-dopa addition to optimized conventional (D2-blocking) antipsychotic treatment? 4. To study whether extrapyramidal symptoms, as frequently seen in patients with schizophrenia who are treated with conventional (D2-blocking) antipsychotic treatment, are reduced by addition of L-dopa.;Primary end point(s): There will be three primary outcome measures. The first primary outcome measure is the change in verbal memory, as compared between patients receiving placebo vs those receiving L-Dopa. Verbal memory is assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R), which is included in the MATRICS. Earlier studies have reported a great difference in verbal memory function between patients with schizophrenia and healthy controls (e.g. Cascella et al., 2008). We expect L-dopa addition will lead to an improvement of verbal memory function of at least 25% towards the level of healthy control subjects. Based on the effect size found in earlier studies comparing patients with schizophrenia with healthy controls (Cascella et al., 2008), a power analysis indicates we would need to include approximately 40 patients in order to reliably show a 25% increase in verbal memory function. The second primary outcome measure is the alteration in working memory as assessed by the N-Back, task as compared between patients receiving placebo vs those receiving L-Dopa. Earlier studies have shown a significant difference in accuracy and reaction time in a 2-back task, between patients with schizophrenia and healthy controls (Schneider et al., 2007; Karch et al, 2009). By ad

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures are change in positive symptoms as assessed by the PANSS positive symptoms score, the improvement in cognitive functions other than verbal memory and working memory, as assessed by the MATRICS, potential changes in frontal functions as assessed by the FAB, decrease of extrapyramidal symptoms as assessed by the ESRS, improvement in general functioning as assessed by the HoNOS, and CGI, and improvement of subjective wellbeing as assessed by the SWN.;Timepoint(s) of evaluation of this end point: PANSS, MATRICS, and ESRS: at 0,1,2,3, and 6 weeks HoNOS: at 0, 1, and 6 weeks FAB, CGI, and SWN: at 0 and 6 weeks	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures are change in positive symptoms as assessed by the PANSS positive symptoms score, the improvement in cognitive functions other than verbal memory and working memory, as assessed by the MATRICS, potential changes in frontal functions as assessed by the FAB, decrease of extrapyramidal symptoms as assessed by the ESRS, improvement in general functioning as assessed by the HoNOS, and CGI, and improvement of subjective wellbeing as assessed by the SWN.;Timepoint(s) of evaluation of this end point: PANSS, MATRICS, and ESRS: at 0,1,2,3, and 6 weeks HoNOS: at 0, 1, and 6 weeks FAB, CGI, and SWN: at 0 and 6 weeks

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Countries

Netherlands

Contacts

Public ContactS. Kushner

Erasmus MC

s.kushner@erasmusmc.nl31107031510

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026