Effect of Melatonin on Schizophrenic Symptoms: a Randomized Placebo-Controlled Trial

NCT06838104 | Active Not Recruiting

• 1 other identifier: LahoreGeneralH2
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia is a chronic mental health disorder that affects thoughts, emotions, and behaviors. It includes positive symptoms such as hallucinations and delusions, as well as negative symptoms like reduced motivation, social withdrawal, and blunted emotional expression. This study is a randomized, placebo-controlled trial designed to evaluate the effect of melatonin on schizophrenia symptoms. Melatonin, a natural hormone that regulates sleep, has antioxidant properties and potential neuroprotective effects. A total of 76 patients diagnosed with schizophrenia according to DSM-5 criteria will be randomly assigned to receive either melatonin (6 mg daily) or a placebo for eight weeks while continuing their standard risperidone-based antipsychotic therapy. Symptoms will be assessed at baseline and after 8 weeks using the Positive and Negative Syndrome Scale (PANSS), a validated tool for measuring schizophrenia severity. The primary outcome will be changes in PANSS scores, evaluating whether melatonin leads to significant improvement compared to placebo. The study hypothesizes that melatonin will significantly reduce positive and negative symptoms compared to placebo. Findings from this research may help determine whether melatonin can be used as an adjunctive treatment in schizophrenia, potentially improving clinical outcomes and quality of life for patients.

Conditions

Schizophrenia Disorders; Psychotic Disorder

Keywords

Antipsychotic Therapy; Positive Symptoms; Negative Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS is a standardized tool used to measure the severity of schizophrenia symptoms, including positive symptoms (hallucinations, delusions), negative symptoms (social withdrawal, lack of motivation), and general psychopathology symptoms. The primary outcome will be the mean change in PANSS total score from baseline to the 8-week follow-up, assessing the effectiveness of melatonin in reducing schizophrenia symptoms.

  Baseline (Week 0) and Week 8

Secondary Outcomes (1)

• Change in PANSS Negative Symptom Subscale Score

  Baseline (Week 0) and Week 8

Study Arms (2)

Melatonin

EXPERIMENTAL

will receive 6 mg of melatonin orally, administered as two 3 mg tablets 30 minutes before bedtime daily for 8 weeks, alongside their standard antipsychotic treatment (risperidone 6-8 mg/day).

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

will receive placebo tablets identical in shape, size, smell, taste, and color to melatonin tablets, administered in the same manner (two tablets 30 minutes before bedtime) for 8 weeks, alongside their standard antipsychotic treatment (risperidone 6-8 mg/day).

Drug: Placebo

Interventions

Melatonin DRUG

Participants in this group will receive 6 mg of melatonin orally, administered as two 3 mg tablets 30 minutes before bedtime daily for 8 weeks, alongside their standard antipsychotic treatment (risperidone 6-8 mg/day).

Melatonin

Placebo DRUG

Participants in this group will receive placebo tablets identical in shape, size, smell, taste, and color to melatonin tablets, administered in the same manner (two tablets 30 minutes before bedtime) for 8 weeks, alongside their standard antipsychotic treatment (risperidone 6-8 mg/day).

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 to 50 years.
• Patients diagnosed with schizophrenia according to DSM-5 criteria, exhibiting both positive negative symptoms.
• Patients who score less than 6 on the Calgary Depression Scale for Schizophrenia (CDSS), indicating no significant depressive episode, will be considered eligible.

You may not qualify if:

• Patients with a known hypersensitivity or allergy to melatonin or any of its excipients.
• Patients with a current or past diagnosis of major depressive disorder, bipolar disorder, or obsessive-compulsive disorder, unless these are in full remission and do not require active pharmacological treatment.
• Patients with any unstable or serious medical condition (e.g., cardiovascular, hepatic, renal, or respiratory diseases) that could interfere with the study outcomes or pose additional risk to the patient.
• Married women of reproductive age, unless they use a reliable non-hormonal contraception method.
• Patients with neurological disorders, such as epilepsy, Parkinson's disease, or traumatic brain injury, which may mimic psychiatric symptoms.
• Use of antiepileptic, antihypertensive, anticoagulant, or anti-platelet drugs.
• Use of inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g., omeprazole, rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil).
• History of addictive disorders.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Muhammad Irfan Jamil

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: December 5, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

PA (1)