Protocol summary
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Study aim
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Investigating the effect of Minocycline for the treatment of the acute phase of mania
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Design
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Randomized double blind and placebo-controlled clinical trial.
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Settings and conduct
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This study will be performed on patients attending Roozbeh Hospital. Patients who meet the inclusion and exclusion criteria will be included.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of bipolar disorder based on DSM-V criteria - Age between 55-18 years - The score of 20 (at least) based on Young Mania Rating Scale. Exclusion criteria: Systemic disease including hypothyroidism or hyperthyroidism - Cardiac conduction disorder - Drug dependence except nicotine and caffeine - Presence of serious suicide risk - IQ less than 70 - History of allergy to any of the used drugs - Pregnant and lactating women - The use of drugs that cause symptoms similar to mania like psychostimulants
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Intervention groups
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Control group: patients receive 900 mg of lithium at baseline toward plasma level of 1.2, 3 mg of risperidone, and placebo, daily.
Intervention group: patients receive 900 mg of lithium at baseline toward the plasma level of 1.2, 3 mg of risperidone, and 100 mg of minocycline, daily.
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Main outcome variables
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Mania severity
General information
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Reason for update
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mistake in type
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N155
Registration date:
2023-12-03, 1402/09/12
Registration timing:
prospective
Last update:
2026-08-08, 1405/05/17
Update count:
1
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Registration date
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2023-12-03, 1402/09/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-21, 1402/11/01
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Expected recruitment end date
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2026-01-21, 1404/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Minocycline as adjuvant therapy for the acute phase of mania: A randomized, double-blind, placebo-controlled trial
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Public title
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Minocycline for the treatment of the acute phase of mania
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of bipolar disorder based on DSM-V criteria
Age between 65-18 years
The score of 20 (at least) based on Young Mania Rating Scale
Exclusion criteria:
Systemic disease including hypothyroidism or hyperthyroidism
Cardiac conduction disorder
Drug dependence except nicotine and caffeine
Presence of serious suicide risk
IQ less than 70
History of allergy to any of the used drugs
Pregnant and lactating women
The use of drugs that cause symptoms similar to mania like psychostimulants
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-01, 1402/08/10
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.429
Health conditions studied
1
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Description of health condition studied
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Bipolar disorder
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ICD-10 code
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F31
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ICD-10 code description
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Bipolar disorder
Primary outcomes
1
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Description
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The severity of manic phase symptoms
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Timepoint
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Weeks: 0 - 2 - 4 - 6
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Method of measurement
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By Young Mania Rating Scale (YMRS)
Intervention groups
1
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Description
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Control group: patients receive 900 mg of lithium at baseline and then increased to obtain plasma level 1.2, 3mg of Risperidone, and placebo, daily for 6 weeks.
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Category
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Placebo
2
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Description
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Intervention group: patients receive 900 mg of lithium at baseline toward the plasma level of 1.2, 3 mg of Risperidone, and 100 mg of Minocycline, daily for 6 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2023 to 2028
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Users should cite the resource of data
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From where data/document is obtainable
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Prof. Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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By e-mail
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Comments
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