Active — Not RecruitingNot Applicable

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

Pakistan76 participantsStarted 2024-12-05

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline (Week 0) and Week 8

Trial details

NCT IDNCT06838104

SponsorLahore General Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06-05

View on ClinicalTrials.gov More Schizophrenia Disorders trials