| CTRI Number |
CTRI/2026/01/100189 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the occurrence of raised prolactin levels in patients taking atypical antipsychotics |
|
Scientific Title of Study
|
To estimate the prevalence of hyperprolactinemia in patients of psychotic disorders treated with atypical antipsychotics: a cross-sectional observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishita |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
7888710494 |
| Fax |
|
| Email |
ishitagupta994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjleen Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9855210999 |
| Fax |
|
| Email |
anjleen9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishita |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
7888710494 |
| Fax |
|
| Email |
ishitagupta994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Patiala |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Patiala |
| Address |
Government Medical College, Patiala, Punjab, 147001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishita |
Rajindra Hospital, Patiala |
Room no 10, Outpatient Department, Department of Psychiatry
Patiala
PUNJAB |
7888710494
ishitagupta994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 18 to 65 years.
2)Diagnosed with a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, delusional disorder) based on DSM-5 criteria.
3)On monotherapy or combination therapy with atypical antipsychotics for at least 4 weeks.
4)Willing to give informed consent and participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)History of pituitary tumors, primary hypothyroidism (ruled out on the basis of T4 and TSH levels), and polycystic ovarian syndrome.
2)Concurrent use of medications known to elevate prolactin (e.g., metoclopramide, domperidone, verapamil, OCPs, opioids).
3)Pregnant or lactating females.
4)Patients with significant medical comorbidities (like CLD, CKD) that may interfere with hormonal regulation or lab testing.
5)Those unwilling or unable to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of hyperprolactinemia in patients of psychotic disorders treated with atypical antipsychotics |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between specific atypical antipsychotic agents & serum prolactin levels |
1 year |
| Clinical & demographic factors associated with hyperprolactinemia |
1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: Psychotic disorders, such as schizophrenia and schizoaffective disorder, are chronic mental illnesses characterized by loss of contact with reality, often requiring long-term antipsychotic treatment. Atypical antipsychotics are widely used due to their better safety profile compared to typical antipsychotics; however, they are associated with significant adverse effects, such as hyperprolactinemia. Elevated serum prolactin levels can lead to various complications such as menstrual irregularities, galactorrhea, sexual dysfunction, infertility, and decreased bone mineral density.
Aim: The aim of this study is to estimate the prevalence of hyperprolactinemia in patients of psychotic disorders treated with atypical antipsychotics and to identify associated demographic and clinical correlates.
Material and Methods: A cross-sectional observational study will be conducted in patients of psychotic disorders who are receiving atypical antipsychotics for at least four weeks. This study will be conducted in the Department of Psychiatry at Government Medical College and Rajindra Hospital, Patiala. The patients who are eligible for the study will be enrolled after taking the written informed consent. After thorough history taking, individual information will be reported in case report form. A blood sample will be withdrawn to estimate serum T4, TSH and PRL levels. Lab reports will be collected and patients with hypothyroidism will be excluded. Data will be analyzed using appropriate statistical methods.
Clinical Significance: This study is expected to identify the prevalence of hyperprolactinemia among atypical antipsychotic users and provide insights into which agents are more associated with elevated prolactin levels. This will aid in better monitoring and management strategies to improve treatment adherence and quality of life in patients with psychotic disorders.
|