Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana

NCT02593734 | Completed Phase 4 DMC

• 1 other identifier: JFR
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.

Conditions

Schizophrenia; Mood Disorders,; Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Brief Psychiatric Rating Scale (BPRS)

  6 weeks

Secondary Outcomes (3)

• Clinical Global Impressions(CGI)

  6 weeks

• Global Assessment of functioning(GAF)

  6 weeks

• De-chaining,

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

No intervention

Experimental

EXPERIMENTAL

The intervention is prescription and dispensing by a nurse of oral antipsychotic or antidepressant medication as clinically indicated. The mediations to be selected from include oral olanzapine, risperidone, amitryptaline or fluoxetine at doses prescribed by the treating psychiatrist.

Drug: olanzapine; Drug: risperidone; Drug: amitryptaline; Drug: fluoxetine

Interventions

olanzapine DRUG

oral antipsychotic drug therapy

Also known as: Zyprexa

Experimental

risperidone DRUG

oral antipsychotic drug therapy

Also known as: Risperdal

Experimental

amitryptaline DRUG

oral antidepressant drug therapy

Also known as: Elavil

Experimental

fluoxetine DRUG

oral drug therapy for depression

Also known as: Prozac

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years,\<70
• Will benefit from treatment
• Not suffering from physical condition
• Resident at the prayer camp
• Not likely to be discharged from camp within six weeks
• Speaks either English or twi
• Able to give consent
• Not already on medication

You may not qualify if:

• likely to be discharged within 6 weeks of commencement of medication
• Patients already on medication

Sponsors & Collaborators

• University of Ghana Medical School: lead

Study Sites (1)

Mount Horeb Prayer Centre

Mamfe, 00233, Ghana

Location

Related Publications (1)

• Ofori-Atta A, Attafuah J, Jack H, Baning F, Rosenheck R; Joining Forces Research Consortium. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial. Br J Psychiatry. 2018 Jan;212(1):34-41. doi: 10.1192/bjp.2017.12.

  PMID: 29433613 DERIVED

MeSH Terms

Conditions

Schizophrenia; Mood Disorders; Anxiety Disorders

Interventions

Olanzapine; Risperidone; Amitriptyline; Fluoxetine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Propylamines; Amines

Study Officials

• Angela L Ofori-Atta, PhD

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: November 2, 2015
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

GH (1)