To study the effect of adding a medicine (called levodopa) to existing treatment in patients with schizophrenia

Phase 2

• Conditions: Health Condition 1: null- SchizophreniaHealth Condition 2: F20- Schizophrenia

• Registration Number: CTRI/2018/08/015367
• Lead Sponsor: Dr Naren P Rao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

(i) SCID-confirmed (Structured Clinical Interview for DSM-IV Axis I

Disorders) diagnosis of schizophrenia

(ii) ages 18-55

(iii) treatment with antipsychotic

monotherapy; antipsychotic dose within, but not below or exceeding, current recommended

guidelines

Exclusion Criteria

(i) history of substance abuse or dependence within 3 months

(ii)positive urine drug screen;

(iii) history or evidence of any disorder that might adversely

influence cognitive measures (e.g. mental retardation);

(iv) presence of serious neurological or

general medical condition (e.g., Parkinsonâ??s disease, cardiac arrhythmia, epilepsy);

(v) clinical

or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic,

pulmonary (including bronchial asthma), or renal disease, narrow-angle glaucoma, malignant

melanoma;

(vi) pregnancy/nursing

(vii) nonselective monoamine oxidase (MAO) inhibitors

within 2 weeks or use of a sympathomimetic amine;

(viii) evidence of acute psychotic

exacerbation in the last month;

(x) acute suicidal risk;

(xi) change in dose of current

antipsychotic or concomitant psychotropic medications in the 8 weeks prior to study entry;

(xii)presence of depressive symptoms, as defined by score >2 on 50% of items (â??moderateâ??), using

the Calgary Depression Scale

(xiii) parkinsonian symptoms, as defined by a score >8 on the

Simpson-Angus Scale for Extrapyramidal Symptoms.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SANS - Schedule for the Assessment of Negative SymptomsTimepoint: 8 weeks