NCT02615652

Brief Summary

Researchers of the three collaborating universities implement a pilot observational study in "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

November 22, 2015

Last Update Submit

May 10, 2017

Conditions

Common Mental Disorders (CMD)Psychotic Symptoms

Outcome Measures

Primary Outcomes (2)

  • psychotic symptoms

    presence of self-reported psychotic symptoms during the month before interview

    through study completion, within 2 months

  • symptoms of Common Mental Disorders

    presence of self-reported CMD symptoms during the month before interview

    through study completion, within 2 months

Secondary Outcomes (2)

  • amount of khat use

    through study completion, within 2 months

  • amount of alcohol use

    through study completion, within 2 months

Interventions

no interventionOTHER

no intervention, observational study

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young adult male inhabitants of the Gilgel Gibe field research center.

You may qualify if:

  • Male, Age 18 - 30, permanent residents in Gilgel Gibe

You may not qualify if:

  • Prior existing severe mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunoassay test for the screening of khat alkaloids in urine.

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Akademischer Rat

Study Record Dates

First Submitted

November 22, 2015

First Posted

November 26, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

May 11, 2017

Record last verified: 2017-05