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

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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

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:

Condition or disease Intervention/treatment Phase
At Risk Mental State (ARMS) Psychosis Drug: Minocycline Drug: Omega-3 fatty acids Drug: Placebo Drug: Minocycline Plus Omega-3 fatty acids Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Minocycline
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Drug: Minocycline
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose

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
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

Active Comparator: Placebo
Placebo added to TAU
Drug: Placebo
Placebo added to TAU

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569307


Contacts
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Contact: Dr.Inti Qurashi, MD Inti.Qurashi@merseycare.nhs.uk
Contact: Prof.Imran B Chaudhry, MD ibchaudhry@btinternet.com

Locations
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Pakistan
Abasi Shaheed Hospital Recruiting
Karachi, Sindh, Pakistan, 72000
Contact: Prof Munir Hamarani, FCPS    00923009272002    mmham@yahoo.com   
Principal Investigator: Prof Munir Hamarani, FCPS         
Civil hospital Karachi Recruiting
Karachi, Sindh, Pakistan, 72000
Contact: Prof Raza U Rahman, FCPS    00-92-21-9215740-50 ext 2500    razaur@yahoo.com   
Principal Investigator: Prof Raza U Rahman, FCPS         
Karwn e Hayat Recruiting
Karachi, Sindh, Pakistan, 72000
Contact: Dr Ajmal Kazmi, MRCPsych    00923213783890    kazmiajmal@yahoo.com   
Principal Investigator: Dr Ajmal Kazmi         
Colleges and Universities Recruiting
Karachi, Sindh, Pakistan
Community Recruiting
Karachi, Sindh, Pakistan
General Practitioners (GPs) Recruiting
Karachi, Sindh, Pakistan
Contact: Dr.Jawahar Lal, FCPS    00923333856799    dr.jawahar81@gmail.com   
Institute of Behavioral Sciences Recruiting
Karachi, Sindh, Pakistan
Contact: Shehla Ahmed         
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
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Principal Investigator: Dr.Inti Qurashi, MD Manchester University ,UK

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02569307     History of Changes
Other Study ID Numbers: PILL-NAYAB-001
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Pakistan Institute of Living and Learning:
At Risk of Mental State
Prodromal Phase
Psychosis

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents