Back to resultsMinocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States (NAYAB)
Primary Purpose
At Risk Mental State (ARMS), Psychosis
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Minocycline
Omega-3 fatty acids
Placebo
Minocycline Plus Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for At Risk Mental State (ARMS) focused on measuring At Risk of Mental State, Prodromal Phase, Psychosis
Eligibility Criteria
Inclusion Criteria:
- Male and female help seeking individuals aged between 16-35 years.
- Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
- Assessed as competent to provide informed consent.
Exclusion Criteria:
- History ofpreviously experiencing a psychotic illness (treated or untreated).
- IQ < 70 and/or history of learning disability.
- Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
- Organic brain disease e.g. epilepsy.
- treatment with an antipsychotic or mood-stabilising agent.
- Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
- Concomitant penicillin therapy or concomitant anticoagulant therapy.
- Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
- Treatment with warfarin or lamotrigine.
- Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
- Current treatment with any anti-inflammatory medication.
- Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
- Active expression of suicidal ideation (CAARMS item 7.3 severity score 6) or current aggression/dangerous behaviour (CAARMS item 5.4 severity score 6). 14. Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.
15. Pregnant or breastfeeding females.
Sites / Locations
- Abasi Shaheed Hospital
- Civil hospital Karachi
- Karwn e Hayat
- Colleges and Universities
- Community
- General Practitioners (GPs)
- Institute of Behavioral Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Minocycline
Omega-3 fatty acids
Placebo
Minocycline Plus Omega-3 fatty acids
Arm Description
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose
Placebo added to TAU
Minocycline+Omega-3 fatty acids added to TAU ,Minocyline will be administered in 200mg once daily dose and Omega-3 fatty acids 1.2 g taken as once daily dose
Outcomes
Primary Outcome Measures
Transition to psychotic disorder
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Secondary Outcome Measures
Measured severity ofAt Risk of Mental State ( ARMS) symptoms
Comprehensive Assessment of At-Risk Mental States (CAARMS) (Berger, GEet al2006).A semi-structured interview that assists in the identification of individuals at risk of developing a first-episode psychotic disorder and measured the severity of ARMS symptoms.
Full Information
NCT ID
NCT02569307
First Posted
October 3, 2015
Last Updated
August 2, 2019
Sponsor
Pakistan Institute of Living and Learning
1. Study Identification
Unique Protocol Identification Number
NCT02569307
Brief Title
Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Acronym
NAYAB
Official Title
A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS. Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to Treatment as Usual in an operationalized ARMS population in Pakistan:
Detailed Description
Primary hypothesis is that the persons with ARMS who are prescribed minocycline and / or Omega-3 fatty acids will have reduced transition rates to psychosis over a one year follow up period (from baseline) compared with Treatment-As-Usual (TAU). The transition rates will be lowest in the group receiving minocycline and Omega-3 fatty acids in combination.
Secondary objective is to determine that the Persons with ARMS who are prescribed minocycline and / or Omega-3fatty acids in combination will have greatest symptom reduction compared with TAU.
This study will be a six-month intervention of minocycline and/or Omega-3 fatty acids added to TAU in patients with ARMS, using a randomised, placebo-controlled, double-blind factorial design.The study will be a four-arm trial: one arm will receive minocycline with TAU; the second arm will receive Omega-3 fatty acids with TAU; the third arm will receive both minocycline and Omega-3 fatty acids with TAU; the fourth arm will receive placebo with TAU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
At Risk Mental State (ARMS), Psychosis
Keywords
At Risk of Mental State, Prodromal Phase, Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minocycline
Arm Type
Active Comparator
Arm Description
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Arm Title
Omega-3 fatty acids
Arm Type
Active Comparator
Arm Description
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo added to TAU
Arm Title
Minocycline Plus Omega-3 fatty acids
Arm Type
Active Comparator
Arm Description
Minocycline+Omega-3 fatty acids added to TAU ,Minocyline will be administered in 200mg once daily dose and Omega-3 fatty acids 1.2 g taken as once daily dose
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo added to TAU
Intervention Type
Drug
Intervention Name(s)
Minocycline Plus Omega-3 fatty acids
Intervention Description
Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
Primary Outcome Measure Information:
Title
Transition to psychotic disorder
Description
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Measured severity ofAt Risk of Mental State ( ARMS) symptoms
Description
Comprehensive Assessment of At-Risk Mental States (CAARMS) (Berger, GEet al2006).A semi-structured interview that assists in the identification of individuals at risk of developing a first-episode psychotic disorder and measured the severity of ARMS symptoms.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female help seeking individuals aged between 16-35 years.
Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
Assessed as competent to provide informed consent.
Exclusion Criteria:
History ofpreviously experiencing a psychotic illness (treated or untreated).
IQ < 70 and/or history of learning disability.
Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
Organic brain disease e.g. epilepsy.
treatment with an antipsychotic or mood-stabilising agent.
Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
Concomitant penicillin therapy or concomitant anticoagulant therapy.
Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
Treatment with warfarin or lamotrigine.
Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
Current treatment with any anti-inflammatory medication.
Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
Active expression of suicidal ideation (CAARMS item 7.3 severity score 6) or current aggression/dangerous behaviour (CAARMS item 5.4 severity score 6). 14. Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.
15. Pregnant or breastfeeding females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Inti Qurashi, MD
Organizational Affiliation
Manchester University ,UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abasi Shaheed Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Civil hospital Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Karwn e Hayat
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Colleges and Universities
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Community
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
General Practitioners (GPs)
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Institute of Behavioral Sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29121974
Citation
Qurashi I, Chaudhry IB, Khoso AB, Farooque S, Lane S, Husain MO, Chu S, Sarginson J, Hamarani M, Naqvi HA, Razzaque B, Minhas FA, Yung AR, Deakin JFW, Husain N. A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol. Trials. 2017 Nov 9;18(1):524. doi: 10.1186/s13063-017-2275-y.
Results Reference
derived
Links:
URL
http://pill.org.pk
Description
Website of Pakistan Institute of Learning and Living
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Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
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