UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048364 |
|---|---|
| Receipt number | R000055125 |
| Scientific Title | Adolescent cannabis use and the later onset of bipolar disorder: a systematic review and meta-analysis of prospective cohort studies |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2024/01/14 08:53:32 |
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Basic information
Public title
Adolescent cannabis use and the later onset of bipolar disorder: a systematic review and meta-analysis of prospective cohort studies
Acronym
Adolescent cannabis use and the later onset of bipolar disorder: a systematic review and meta-analysis of prospective cohort studies
Scientific Title
Adolescent cannabis use and the later onset of bipolar disorder: a systematic review and meta-analysis of prospective cohort studies
Scientific Title:Acronym
Adolescent cannabis use and the later onset of bipolar disorder: a systematic review and meta-analysis of prospective cohort studies
Region
| Japan |
Condition
Condition
cannabis use, bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to systematically review and analyze longitudinal prospective cohort studies that measured cannabis use during adolescence and evaluate the onset of bipolar disorder.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The onset of bipolar disorder by the self-reported questionnaires or structured interviews.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Studies that included participants who were general population, including those with risk factors such as a family history of bipolar disorders.
2.Studies that assessed cannabis use in adolescents (at least 1 assessment point) and then again assessed them for bipolar disorders later.
3.Studies that used a prospective cohort design.
4.Studies published in English or Japanese.
5.Studies published in peer-reviewed journals.
Key exclusion criteria
1.Studies with participants primarily diagnosed with bipolar disorders, or psychotic disorders such as schizophrenia, and schizoaffective disorder.
2.Studies including reviews, letters, commentaries, conference abstracts will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Naonroi |
| Middle name | |
| Last name | Yasuma |
Organization
Ageonomori clinic
Division name
Department of Psychiatry
Zip code
362-0067
Address
1 Chome-174-2 Nakabun, Ageo, Saitama
TEL
048-725-0378
nnyy712@gmail.com
Public contact
Name of contact person
| 1st name | Naonori |
| Middle name | |
| Last name | Yasuma |
Organization
Ageonomori clinic
Division name
Department of Psychiatry
Zip code
362-0067
Address
1 Chome-174-2 Nakabun, Ageo, Saitama
TEL
048-725-0378
Homepage URL
nnyy712@gmail.com
Sponsor or person
Institute
Ageonomori clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary analyses
We will synthesise adolescent cannabis use and the later onset of bipolar disorder assessed as dichotomous variables. Meta-analysis will be conducted when at least three eligible studies can be collected. A fixed-effect model will be used if heterogeneity is not observed, otherwise a random-effects model will be used. Heterogeneity will be assessed using the Cochrans Q test and I2.
Subgroup analyses
We will be conducted by 1) studies that assessed the outcome variable (bipolar disorders) was controlled for at baseline and 2) studies whose outcome were assessed by the structured interview.
Risk of bias
We will use Risk Of Bias In Non randomised Studies of Interventions; ROBINS-I.
Publication bias
We will assess publication bias by using funnel plots and Egger's tests.
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055125
