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A study of the effect of Alpha lipoic acid in addition to the usual treatment drug in schizophrenia patients

A Randomized Double Blind Placebo Controlled trial Evaluating the Efficacy of Alpha Lipoic Acid as Add-On Therapy on Cognitive Impairment in Schizophrenia Patients of a Tertiary Care Hospital - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060745
Enrollment
72
Registered
2023-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: Alpha lipoic acid: Alpha lipoic acid Administration of ALA 300 mg oral once daily for 3 months as an adjunct to antipsychotic medication Control Intervention1: Placebo: Placebo once dai

Sponsors

Dr Ramya R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Schizophrenia diagnosis made by research psychiatrists using the Structured Clinical Interview, SCID-5, for Diagnostic and Statistical Manual of Mental Disorders of more than 2 years duration and on treatment 2)Cognitive symptoms despite adequate antipsychotic treatment assessed by MOCA scored 3)Age 18-60 years of either gender 4)Willing to participate

Exclusion criteria

Exclusion criteria: 1)6-months history of any drug or alcohol abuse or dependence 2)Changes in psychotropic medications within the last 4 weeks and patients on valproate use (potential interaction with ALA) 3)Women who are planning to become pregnant, are pregnant, or are breastfeeding 4)Known chronic infections such as HIV or hepatitis C, and liver or renal failure that could adversely impact on patient outcome

Design outcomes

Primary

MeasureTime frame
1) Effect of alpha lipoic acid on executive functioning-attention, inhibition, working memory, Orientation through Montreal Cognition Assessment scaleTimepoint: Baseline to 12 weeks

Secondary

MeasureTime frame
1)Effect of alpha lipoic acid on improving cognition and disability 2) Effect of alpha lipoic acid on quality of lifeTimepoint: Baseline to 12 weeks

Countries

India

Contacts

Public ContactDr V Sathyanarayanan

SRM medical college

sathyanv@srmist.edu.in9384633405

Outcome results

None listed

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