| CTRI Number |
CTRI/2021/12/038752 [Registered on: 20/12/2021] Trial Registered Prospectively |
| Last Modified On: |
19/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Minocycline as an adjunctive therapy in patients with bipolar mania |
|
Scientific Title of Study
|
Minocycline as an adjunctive therapy in patients with bipolar mania: A randomized double blind placebo controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harrishupreet Kaur |
| Designation |
Post Graduate Student |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Flat No. 4, Doctors Flats, Central Institute of Psychiatry, Kanke Ranchi Jharkhand 834006, India
118 Avas Vikas Colony Veerbhadra Road Rishikesh Uttarakhand 249201
Ranchi
JHARKHAND
834006
India |
| Phone |
9878912715 |
| Fax |
|
| Email |
harrishupreetkaur03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roshan V Khanande |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department office, Central Institute of Psychiatry, Kanke Ranchi Jharkhand 834006, India
Ranchi
JHARKHAND
834006
India |
| Phone |
7070896004 |
| Fax |
|
| Email |
roshankhanande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roshan V Khanande |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department office, Central Institute of Psychiatry, Kanke Ranchi Jharkhand 834006, India
Ranchi
JHARKHAND
834006
India |
| Phone |
7070896004 |
| Fax |
|
| Email |
roshankhanande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke Ranchi Jharkhand 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke Ranchi Jharkhand 834006 |
| 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 |
| Harrishupreet Kaur |
Central Institute of Psychiatry, Ranchi, Jharkhand |
Male and Female Wards, Department of Psychiatry
Ranchi
JHARKHAND |
9878912715
harrishupreetkaur03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Institute of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adjunctive Minocycline Therapy |
Tablet minocycline 100 mg BD orally for 6 weeks in patients with Bipolar mania along with usual treatment |
| Comparator Agent |
Placebo |
Tablet Placebo BD orally for 6 weeks with usual treatment in patients of bipolar mania |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria for group 1 (Minocycline) and Group 2 (Placebo)
1. Male inpatients satisfying the ICD 10-DCR[1993] criteria of Bipolar affective disorder, current episode mania with YMRS score of >20.
2.Age group of 18-50 years.
3.Drug naive or drug free patients for minimum 2 weeks for mood stabilisers/antipsychotics and 4 weeks for depot antipsychotics.
4. Those who give informed consent for participating in the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for group 1 (Minocycline) and Group 2 (Placebo)
1. Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.
2. Significant current/ past medical or neurological illness including severe hepatic disease and history of severe head injury .
3. Known hypersensitivity to Tab. Minocycline or any of its components.
4. Patients who had received ECT in last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Tab. Minocycline (200mg/day) as an adjunctive therapy assessed by YMRS BPRS and CGI scores in patients with bipolar mania. |
Baseline, 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the levels of IL-1β-converting enzyme, iNOS,and Bcl-2 in patients receiving adjunctive Tab. Minocycline (200 mg/day). |
Baseline, 2 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/12/2021 |
| 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="2"
Months="6"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As an inhibitor of microglial activation, Minocycline has anti-inflammatory, antioxidant, and antiapoptotic properties, and can modulate glutamate-induced excitotoxicity and neuroprotective effects. These pathways have all been implicated in the causation of mood disorders. Other anti-inflammatory drugs such as Aspirin, Celecoxib, N-acetyl cystiene, Omega3 fatty acids and Pioglitazone has evidence of effectiveness in bipolar depression or mixed episopdes. Also Minocycline as an anti-inflammatory and neuroprotective drug have already shown improvement as an adjunctive treatment in schizophrenia, autism, bipolar depression, along with other neuropsychiatric conditions. Nevertheless, there is only one preclinical study showing effectiveness of Minocycline in bipolar mania and no clinical studies suggesting the same. Therefore we want to use Minocycline as a new adjunctive treatment modality in bipolar mania due to its peculiar properties. |