At Risk Mental State (ARMS)Phase 2NAYABNCT02569307
Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
A Phase 2 study testing Minocycline, Omega-3 fatty acids and Minocycline Plus Omega-3 fatty acids in people with At Risk Mental State (ARMS) and Psychosis, run by Pakistan Institute of Living and Learning at 7 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- At Risk Mental State (ARMS), Psychosis
- What is being tested?
- Minocycline, Omega-3 fatty acids and Minocycline Plus Omega-3 fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 7 sitesPakistan
- Study dates
- Oct 2015to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Pakistan7 sites
Abasi Shaheed Hospital
Karachi, Sindh, 72000
Civil hospital Karachi
Karachi, Sindh, 72000
Karwn e Hayat
Karachi, Sindh, 72000
Colleges and Universities
Karachi, Sindh
Community
Karachi, Sindh
General Practitioners (GPs)
Karachi, Sindh
Institute of Behavioral Sciences
Karachi, Sindh
About this study
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
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:
Read the 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.
- Conditions
- At Risk Mental State (ARMS), Psychosis
- Being tested
- Minocycline, Omega-3 fatty acids, Placebo, Minocycline Plus Omega-3 fatty acids
- Keywords
- At Risk of Mental State, Prodromal Phase, Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
Omega-3 fatty acidsDrug
Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
PlaceboDrug
Placebo added to TAU
Minocycline Plus Omega-3 fatty acidsDrug
Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Active comparator | Minocycline added to TAU Minocycline will be administered in 200mg once daily dose Receives: Drug: Minocycline |
| Omega-3 fatty acids | Active comparator | Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose Receives: Drug: Omega-3 fatty acids |
| Placebo | Active comparator | Placebo added to TAU Receives: Drug: Placebo |
| Minocycline Plus Omega-3 fatty acids | Active comparator | 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 Receives: Drug: Minocycline Plus Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition to psychotic disorder
Structure Clinical interview for DSM-IV(SCID) (Michael B et al,. 2002) to confirm the transition to psychosis.
Measured: 12 Months
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for At Risk Mental State (ARMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Inti Qurashi, MD, Principal investigator, Manchester University ,UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569307
- Sponsor's protocol ID
- PILL-NAYAB-001
- Acronym
- NAYAB
- Status last verified
- Aug 2019
- First submitted
- 3 Oct 2015
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29121974
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02569307
- Acronym / sponsor ID
- NAYAB / PILL-NAYAB-001
- Conditions
- At Risk Mental State (ARMS), Psychosis
- Keywords
- At Risk of Mental State, Prodromal Phase, Psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Active comparator | Drug: MinocyclineMinocycline added to TAU Minocycline will be administered in 200mg once daily dose |
| Omega-3 fatty acids | Active comparator | Drug: Omega-3 fatty acidsOmega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2mg once daily dose |
| Placebo | Active comparator | Drug: PlaceboPlacebo added to TAU |
| Minocycline Plus Omega-3 fatty acids | Active comparator | Drug: Minocycline Plus Omega-3 fatty acidsMinocycline+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 |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline added to TAU Minocycline will be administered in 200mg once daily dose | Drug | Minocycline |
| Omega-3 fatty acidsOmega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose | Drug | Omega-3 fatty acids |
| PlaceboPlacebo added to TAU | Drug | Placebo |
| Minocycline Plus Omega-3 fatty acidsMinocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose | Drug | Minocycline Plus Omega-3 fatty acids |
Primary outcome
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.
1 secondary outcome
Measured severity ofAt Risk of Mental State ( ARMS) symptoms
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 29121974Qurashi 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.
- Website of Pakistan Institute of Learning and LivingLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Inti Qurashi, MD principal investigator
Manchester University ,UK
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline, Omega-3 fatty acids and Minocycline Plus Omega-3 fatty acids in people with At Risk Mental State (ARMS) and Psychosis, run by Pakistan Institute of Living and Learning at 7 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition to psychotic disorder (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02569307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.