Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States (NAYAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02569307
Recruitment Status : Recruiting
First Posted : October 6, 2015
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Tracking Information
First Submitted Date  ICMJE October 3, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2015)
Transition to psychotic disorder [ Time Frame: 12 Months ]
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02569307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2015)
Measured severity ofAt Risk of Mental State ( ARMS) symptoms [ Time Frame: 12 Months ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • At Risk Mental State (ARMS)
  • Psychosis
Intervention  ICMJE
  • Drug: Minocycline
    Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
  • Drug: Omega-3 fatty acids
    Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
  • Drug: Placebo
    Placebo added to TAU
  • Drug: Minocycline Plus Omega-3 fatty acids
    Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
Study Arms  ICMJE
  • Active Comparator: Minocycline
    Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
    Intervention: Drug: Minocycline
  • Active Comparator: Omega-3 fatty acids
    Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose
    Intervention: Drug: Omega-3 fatty acids
  • Active Comparator: Placebo
    Placebo added to TAU
    Intervention: Drug: Placebo
  • Active Comparator: Minocycline Plus Omega-3 fatty acids
    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: Drug: Minocycline Plus Omega-3 fatty acids
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2015)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female help seeking individuals aged between 16-35 years.
  2. Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
  3. Assessed as competent to provide informed consent.

Exclusion Criteria:

  1. History ofpreviously experiencing a psychotic illness (treated or untreated).
  2. IQ < 70 and/or history of learning disability.
  3. Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
  4. Organic brain disease e.g. epilepsy.
  5. treatment with an antipsychotic or mood-stabilising agent.
  6. Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
  7. Concomitant penicillin therapy or concomitant anticoagulant therapy.
  8. Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
  9. Treatment with warfarin or lamotrigine.
  10. Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
  11. Current treatment with any anti-inflammatory medication.
  12. Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
  13. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr.Inti Qurashi, MD Inti.Qurashi@merseycare.nhs.uk
Contact: Prof.Imran B Chaudhry, MD ibchaudhry@btinternet.com
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569307
Other Study ID Numbers  ICMJE PILL-NAYAB-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pakistan Institute of Living and Learning
Study Sponsor  ICMJE Pakistan Institute of Living and Learning
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr.Inti Qurashi, MD Manchester University ,UK
PRS Account Pakistan Institute of Living and Learning
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP