To compare two dugs ,Olanzapine and Haloperidol in psychosis patients.

A Randomized Controlled Trial comparing the efficacy and safety of Olanzapine and Haloperidol , and its assessment with homocysteine in schizophrenia patients - OLHALOHOMSCHIZO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/11/016425

Enrollment

Registered

2018-11-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: F259- Schizoaffective disorder, unspecified Health Condition 2: F259- Schizoaffective disorder, unspecified Health Condition 3: F259- Schizoaffective disorder, unspecified

Interventions

Intervention1: OLANZAPINE: Tablet Olanzapine 25mg PO OD after food for 28 days then follow up on 3rd month and 6th month Control Intervention1: HALOPERIDOL: Tablet Haloperidol 15mg PO OD after food fo

Eligibility

Inclusion criteria

Inclusion criteria: A newly diagnosed schizophrenia acording to DSM-V criteria

Exclusion criteria

Exclusion criteria: Known allergic to Olanzapine or Haloperidol -Unstable patients unable to give consent for the study -Liver failure and kidney failure patients -Pregnant women and lactating mothers -Subject who is currently enrolled in another investigational drug study

Design outcomes

Primary

Measure	Time frame
Primary Objective To compare efficacy of Olanzapine and Haloperidol in schizophrenia patients To estimate the Co- relation of homocysteine and clinical improvement of symptoms Timepoint: Primary end point : -Clinical improvement of symptoms assessed by mean change from baseline to endpoint(day 14 and 28) in total scores using BPRS scale. -Change in homocysteine from baseline to day 14 and day 28 of treatment	—

Measure

Time frame

Primary Objective To compare efficacy of Olanzapine and Haloperidol in schizophrenia patients To estimate the Co- relation of homocysteine and clinical improvement of symptoms Timepoint: Primary end point : -Clinical improvement of symptoms assessed by mean change from baseline to endpoint(day 14 and 28) in total scores using BPRS scale. -Change in homocysteine from baseline to day 14 and day 28 of treatment

—

Secondary

Measure	Time frame
To assess saftey parametersTimepoint: Secondary end point : -Extrapyramidal symptoms severity is assessed on the first visit and is compared on day 14 and day28 of treatment by using Abnormal Involuntary Movement Scale (AIMS) is a screening tool that assesses extrapyramidal adverse effects -To evaluate safety in terms of Adverse effects occurrence and altered lab parameters	—

Countries

India

Contacts

Public ContactVENKATA AKSHEENA VARAHI VEDAM

Sri Ramachandra Medical College and Research Institute

daviddolly@rediff.com9444622698

Outcome results

None listed

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