MCAZ CTR:: Applications

PUBLIC TITLE/ACRONYM	The Friendship Bench Plus trial (FB+Trial)
Scientific Title	Combining antidepressants with psychological therapy to improve depression outcome in Zimbabwe - the Friendship Bench Plus trial (FB+Trial)
Primary Sponsor Details
Sponsors *	University Hospital of Psychiatry and Psychotherapy Bern
Secondary Sponsor Details
Sponsors	Swiss National science Foundation
Contact for Public Queries
Name	Rukudzo Mwamuka
Designation	Study coordinator
Email	ruemwamuka.tsungu@gmail.com
Phone number	0777065549
Postal Address	4 Cuba Avenue Mt Pleasant Harare
Affiliation	University of Bern
Contact for Scientific Queries
Name	Dickson Chibanda
Designation	Principal Investigator
Email	dixon.chibanda@frienshipbench.io
Phone number	0712204107
Postal Address	4 Weale Road Milton Park
Affiliation	University of Zimbabwe
Countries of Recruitment
Zimbabwe

Source of Funds	Foreign

Health Condition(s) or Problem(s) Studied	Depression

Medicine Name	Fluoxetine
Quantity of medicine required	40000 tablets

7.0 PRINCIPAL INCLUSION CRITERIA
We will include adults ≥18 years with moderate to severe depression defined as PHQ-9 ≥ 11 who are treatment naïve to the FB at the time of recruitment.
7.1 PRINCIPAL EXCLUSION CRITERIA
Exclusion criteria will be: mild depression defined as PHQ-9 <11; receiving specialist mental health care including antidepressants at the time of recruitment; pregnancy (urine pregnancy test will be performed); history of serious physical health problem (kidney failure, liver failure, serious heart disease, cancer, end-stage AIDS); presenting with high suicidal risk; presenting with psychotic symptoms; or unable to comprehend the nature of the study in either English or Shona (local language).
7.2 PRIMARY END POINTS
Our primary outcome will be treatment response after four months defined as ≥ 50% improvement in the PHQ-9 score as compared to baseline Remission after four months defined as PHQ-9<5 will be our key secondary outcome.

9.0 DESIGN OF THE TRIAL
Type of trial	Controlled
If controlled
Randomised	Yes
Single Blind	No
Double Blind	No
Parallel group	No
Cross over	No
Other	No
If yes to other, specify
If controlled, specify the comparator	The Friendship Bench psychological intervention
Other medicinal product(s)	No
Placebo	No
Other	No
If yes to other, specify
Other	No

Expected Number of participants in Zimbabwe	296
Total enrolment in each site: (if competitive enrolment, state minimum and maximum number per site.)	296
Total participants worldwide	296

Time period for the trial	August 2024 to 31 December 2028

Medicines Control Authority of Zimbabwe