| CTRI Number |
CTRI/2024/09/073729 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life in schizophrenia patients not taking medication |
|
Scientific Title of Study
|
A retrospective study of pharmacological non-compliance in patients of schizophrenia with respect to quality of life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KOTLA RISHITHA |
| Designation |
Junior Resident |
| Affiliation |
DATTA MEGHE INSTITUE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department Of Psychiatry, Jawahar Lal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi, Wardha, Maharashtra - 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7095726957 |
| Fax |
|
| Email |
kotla.rishitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P S PATIL |
| Designation |
Professor |
| Affiliation |
DATTA MEGHE INSTITUE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department Of Psychiatry, Jawahar Lal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi, Wardha, Maharashtra - 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8999248979 |
| Fax |
|
| Email |
dr.p.s.patil2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KOTLA RISHITHA |
| Designation |
Junior Resident |
| Affiliation |
DATTA MEGHE INSTITUE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department Of Psychiatry, Jawahar Lal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi, Wardha, Maharashtra - 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7095726957 |
| Fax |
|
| Email |
kotla.rishitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH,SAWANGI, MEGHE, MAHARASHTRA, INDIA -422001 |
|
|
Primary Sponsor
|
| Name |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Datta Meghe Institute Of Higher Education And Research, Department Of Psychiatry, Wardha, Maharashtra - 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra, India- 442001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kotla Rishitha |
Acharya Vinobha Bhave Rural Hospital |
Department of Psychiatry, AVBRH
Wardha
MAHARASHTRA |
7095726957
kotla.rishitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research(DMIHER) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
Patients who are clinically diagnosed to have Schizophrenia using the International Classification of Diseases 11th revision (ICD-11) research criteria
Patients within the age group of 18 to 65 years.
The patient should be able to give written, informed consent.
Patient should be non-compliant at least for a period of 2 months .
Patients should be compliant at least for a period of a year.
|
|
| ExclusionCriteria |
| Details |
Subjects are not willing to give written informed consent.
Patients who are acutely ill or are not able to cooperate with the study
Patients who have a history of developmental delay or any other major organic brain pathology.
Patient who had history of head injury.
Patients who have been non- compliant for less than 2 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comprehensive outcome of poor compliance to Treatment of Schizophrenia on the outcome of disease. |
Assessments will be done at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/10/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Schizophrenia is a mental disorder that disrupts
thought processes, perceptions, emotional responsiveness, and social
interactions. Although the course of schizophrenia differs from person to
person, it is usually chronic and can be severe and disabling, resulting in
significant impairments in quality of life. As treatment As approaches evolved, more emphasis was placed on re-integrating patients into
their psychosocial environments rather than simply monitoring psychotic
symptoms. With the increasing availability of a wide range of drugs to treat
mental illnesses, psychotropic medications are now an essential component in
the treatment of patients with severe mental disorders. In For patients with schizophrenia, quality of life is an important aspect of
recovery. Quality of life (QoL) is a term that refers to the wellbeing of a
population or an individual in terms of both positive and negative aspects of
their existence at a particular time. Personal health (physical,
mental and spiritual), relationships, education status, work environment,
social status, wealth, a sense of security and safety, freedom, and autonomy in
decision-making, social-belonging, and their physical surroundings are examples
of common aspects of QoL. According to Boyer et al., one of the most important variables in
determining the recurrence of schizophrenia is QoL. The better the patient’s quality of life, the less likely they are to relapse within two years. The
development of second-generation antipsychotics raised expectations that these
medications would improve quality of life more than traditional antipsychotics. Nearly one-third of people who suffer major psychiatric disorders globally end
up with a long-term disability and dependency. However, very few
Indian studies have compared the change in quality-of-life following treatment
with typical and atypical antipsychotics. |