NCT06838104Active, not recruiting
Effect of Melatonin on Schizophrenic Symptoms: a Randomized Placebo-Controlled Trial
Effect of Melatonin on Positive and Negative Symptoms of Schizophrenic Patients: a Randomized Placebo-Controlled Study
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 15 Feb 2025
- Start date
- 5 Dec 2024
- Primary completion date
- 5 Jun 2025
- Lead sponsor
- Lahore General Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT06838104
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 5 Dec 2024 to the primary completion date, 5 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g., omeprazole, rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil).
Other illness
- 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.
- Patients with neurological disorders, such as epilepsy, Parkinson's disease, or traumatic brain injury, which may mimic psychiatric symptoms.
- History of addictive disorders.
Lab values
- Use of antiepileptic, antihypertensive, anticoagulant, or anti-platelet drugs.
Age
- Married women of reproductive age, unless they use a reliable non-hormonal contraception method.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lahore General Hospital, Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.