Schizophrenia DisordersNCT06838104
Effect of Melatonin on Schizophrenic Symptoms: a Randomized Placebo-Controlled Trial
A study testing Melatonin in people with Schizophrenia Disorders and Psychotic Disorder, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia Disorders, Psychotic Disorder
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Dec 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Effect of Melatonin on Positive and Negative Symptoms of Schizophrenic Patients: a Randomized Placebo-Controlled Study
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.
Read more
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.
Read the detailed description
Schizophrenia is a chronic psychiatric disorder characterized by a combination of positive symptoms (hallucinations, delusions, disorganized thinking) and negative symptoms (social withdrawal, reduced motivation, and blunted affect). While antipsychotic medications remain the primary treatment, they often fail to address negative symptoms, which are strongly associated with poor functional prognosis and reduced quality of life. Emerging evidence suggests that melatonin, a neurohormone primarily responsible for sleep regulation, possesses antioxidant and neuroprotective properties that may contribute to symptom improvement in schizophrenia.
This randomized, placebo-controlled trial aims to evaluate the efficacy of melatonin supplementation as an adjunct to standard antipsychotic therapy (risperidone 6-8 mg/day) in patients diagnosed with schizophrenia. The study will enroll 76 patients, randomly assigned to receive either melatonin (6 mg daily, administered as two 3 mg tablets before bedtime) or a placebo identical in shape, size, color, and taste for eight weeks. Participants will continue their standard antipsychotic regimen throughout the study period.
The primary outcome of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8, assessing the overall impact of melatonin on symptom severity. The secondary outcomes include changes in PANSS negative symptom subscale scores, evaluating whether melatonin improves motivation, emotional expression, and social engagement.
To ensure methodological rigor, patients will be assessed at baseline and after eight weeks using the PANSS scoring system. Randomization will be performed using a lottery method, and the study will follow a double-blind design, ensuring that neither patients nor investigators are aware of the treatment allocation. Safety monitoring will include adverse event reporting, particularly evaluating the incidence of excessive sedation, dizziness, headache, and gastrointestinal disturbances.
This study aims to provide clinical evidence regarding the role of melatonin as an adjunctive treatment for schizophrenia. If proven effective, melatonin supplementation could offer a low-cost, well-tolerated intervention to enhance treatment outcomes in schizophrenia patients, particularly those experiencing persistent negative symptoms.
- Conditions
- Schizophrenia Disorders, Psychotic Disorder
- Being tested
- Melatonin, Placebo
- Keywords
- Antipsychotic Therapy, Positive Symptoms, Negative Symptoms
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 8
Secondary outcomes (1)
Change in PANSS Negative Symptom Subscale Score
The PANSS negative symptom subscale consists of seven items, measuring deficits in emotional expression, motivation, speech, and social engagement. The score ranges from 7 to 49, with higher scores reflecting more severe negative symptoms. The mean change from baseline to Week 8 will be analyzed to assess the impact of melatonin on negative symptoms.
Measured: Baseline (Week 0) and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start5 Dec 2024
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Muhammad Irfan Jamil, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838104
- Sponsor's protocol ID
- LahoreGeneralH2
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Positive and Negative Symptoms of Schizophrenic Patients: a Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06838104
- Acronym / sponsor ID
- LahoreGeneralH2
- Conditions
- Schizophrenia Disorders, Psychotic Disorder
- Keywords
- Antipsychotic Therapy, Positive Symptoms, Negative Symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Schizophrenia is a chronic psychiatric disorder characterized by a combination of positive symptoms (hallucinations, delusions, disorganized thinking) and negative symptoms (social withdrawal, reduced motivation, and blunted affect). While antipsychotic medications remain the primary treatment, they often fail to address negative symptoms, which are strongly associated with poor functional prognosis and reduced quality of life. Emerging evidence suggests that melatonin, a neurohormone primarily responsible for sleep regulation, possesses antioxidant and neuroprotective properties that may contribute to symptom improvement in schizophrenia.
This randomized, placebo-controlled trial aims to evaluate the efficacy of melatonin supplementation as an adjunct to standard antipsychotic therapy (risperidone 6-8 mg/day) in patients diagnosed with schizophrenia. The study will enroll 76 patients, randomly assigned to receive either melatonin (6 mg daily, administered as two 3 mg tablets before bedtime) or a placebo identical in shape, size, color, and taste for eight weeks. Participants will continue their standard antipsychotic regimen throughout the study period.
The primary outcome of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8, assessing the overall impact of melatonin on symptom severity. The secondary outcomes include changes in PANSS negative symptom subscale scores, evaluating whether melatonin improves motivation, emotional expression, and social engagement.
To ensure methodological rigor, patients will be assessed at baseline and after eight weeks using the PANSS scoring system. Randomization will be performed using a lottery method, and the study will follow a double-blind design, ensuring that neither patients nor investigators are aware of the treatment allocation. Safety monitoring will include adverse event reporting, particularly evaluating the incidence of excessive sedation, dizziness, headache, and gastrointestinal disturbances.
This study aims to provide clinical evidence regarding the role of melatonin as an adjunctive treatment for schizophrenia. If proven effective, melatonin supplementation could offer a low-cost, well-tolerated intervention to enhance treatment outcomes in schizophrenia patients, particularly those experiencing persistent negative symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatoninwill 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). |
| Placebo | Placebo comparator | Drug: Placebowill 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants 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). | Drug | Melatonin |
| PlaceboParticipants 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). | Drug | Placebo |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline (Week 0) and Week 8
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.
1 secondary outcome
Change in PANSS Negative Symptom Subscale Score
Time frame: Baseline (Week 0) and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Related trials for Schizophrenia Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Irfan Jamil principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Schizophrenia Disorders and Psychotic Disorder, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline (Week 0) and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.