Delving into the Latest Updates on Gabapentin with Synapse

Overview

Basic Info

SummaryGabapentin is a small molecule drug developed by Pfizer that functions as a CACNA2D2 and Cav2.2 blocker. The drug has been approved for the treatment of various conditions, including anxiety, cough, diabetic neuropathies, epilepsy, fibromyalgia, restless legs syndrome, and seizures. Gabapentin's mechanism of action involves blocking the influx of calcium ions into neurons, thereby reducing their excitability and relieving symptoms such as pain and convulsions. Since its initial approval in 1993, Gabapentin has become a widely prescribed medication for the treatment of these conditions. However, it is important to note that Gabapentin may cause certain side effects, such as drowsiness, dizziness, and difficulty with coordination. Therefore, its use must be closely monitored by healthcare providers, and patients should follow the prescribed dosage and usage guidelines.

Drug Type

Small molecule drug

Synonyms

1-(Aminomethyl)cyclohexaneacetic acid, Gabapentin (JAN/USP/INN)

+ [16]

Target

CACNA2D1 x CACNA2D2

Mechanism

CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEndocrinology and Metabolic Disease+ [3]

Active Indication

Peripheral neuralgiaNeuralgia, PostherpeticAnxiety Disorders+ [7]

Inactive Indication

Amyotrophic Lateral SclerosisCarpal Tunnel SyndromeDyspepsia+ [6]

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Parke Davis (India) Ltd.Gebr. Gödecke Beteiligungs- und Verwaltungsgesellschaft mbH

+ [4]

Inactive Organization

Assertio Therapeutics, Inc.

Viatris, Inc.Hunter New England Area Health Service

Drug Highest PhaseApproved

First Approval Date

US (30 Dec 1993),

Anxiety DisordersCoughDiabetic Neuropathies+ [5]

RegulationOrphan Drug (US)

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Structure/Sequence

Molecular FormulaC9H17NO2

InChIKeyUGJMXCAKCUNAIE-UHFFFAOYSA-N

CAS Registry60142-96-3

Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Florida

100 Clinical Results associated with Gabapentin

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100 Translational Medicine associated with Gabapentin

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100 Patents (Medical) associated with Gabapentin

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7,927

Literatures (Medical) associated with Gabapentin

01 Dec 2025·Current Allergy and Asthma Reports

Treatment of COVID-19 Associated Olfactory Dysfunction: A Systematic Review

Review

Author: Vanderbroek, Annabelle ; Clijsters, Marnick ; Moyaert, Mathilde ; Van Gerven, Laura ; Bischoff, Sabrina

PURPOSE OF REVIEWCOVID -19 associated olfactory dysfunction is widespread, yet effective treatment strategies remain unclear. This article aims to provide a comprehensive systematic review of therapeutic approaches and offers evidence-based recommendations for their clinical application.RECENT FINDINGSA living Cochrane review, with rigorous inclusion criteria, has so far included 2 studies with a low certainty of evidence. In this systematic review we list clinical data of 36 randomised controlled trials (RCTs) and non-randomised studies published between Jan 1, 2020 and Nov 19, 2023 regarding treatment options for COVID-19 associated olfactory dysfunction. Nine treatment groups were analysed, including olfactory training, local and systemic corticosteroids, platelet-rich plasma (PRP), calcium chelators, vitamin supplements including palmitoylethanolamide with luteolin, insulin, gabapentin and cerebrolysin. Primary objective was the effect of the studied treatments on the delta olfactory function score (OFS) for objective/psychophysical testing. Treatments such as PRP and calcium chelators demonstrated significant improvements on OFS, whereas olfactory training and corticosteroids did not show notable efficacy for COVID-19 associated olfactory dysfunction.

01 Mar 2025·Radiology Case Reports

Wyburn-Mason disease: Management of a Spetzler-Martin grade 5 arteriovenous malformation with predominant thalamic involvement

Article

Author: Dhatt, Jovan ; Kuwabara, Michael ; Szymanski, Kathryn A ; Halderman, Kelly ; Houser, Karis

Wyburn-Mason disease (WMD) is a rare congenital phakomatosis known for its complex arteriovenous malformations (AVMs) predominantly affecting the brain and ocular structures. We present the case of a 19-year-old female with an unruptured Spetzler-Martin grade 5 left thalamic AVM, who initially exhibited progressive visual impairment and migraines. Following diagnosis, she was treated with trametinib, a MEK inhibitor; however, nine months later, she developed acute complications, including left monocular blindness and right hemisensory loss. Imaging revealed narrowing of the left internal carotid artery and ischemia, leading to the discontinuation of trametinib. Her condition stabilized with gabapentin and supportive therapies. This case emphasizes the potential therapeutic role and risks of MEK inhibitors in managing high-grade AVMs in WMD and highlights the need for individualized management and careful monitoring in such cases.

01 Mar 2025·Journal of Hazardous Materials

Profiling trace organic chemical biotransformation genes, enzymes and associated bacteria in microbial model communities

Article

Author: Cao, Lijia ; Wurzbacher, Christian ; Garcia, Sarahi L

Microbial biotransformation of trace organic chemicals (TOrCs) is an essential process in wastewater treatment to eliminate environmental pollution. Understanding TOrC biotransformation mechanisms, especially at their original concentrations, is important to optimize treatment performance, whereas our current knowledge is limited. Here, we investigated the biotransformation of seven TOrCs by 24 model communities. The genome-centric analyses unraveled potential biotransformation drivers concerning functional genes, enzymes, and responsible bacteria. We obtained efficient model communities for completely removing ibuprofen, caffeine, and atenolol, with transformation efficiencies between 0 % and 45 % for sulfamethoxazole, carbamazepine, trimethoprim, and gabapentin. Biotransformation performance was not fully reflected by the presence of known biotransformation genes and enzymes in the metagenomes of the communities. Functional similar homologs to existing biotransformation genes and enzymes (e.g., long-chain-fatty-acid-CoA ligase encoded by fadD and fadD13 gene) could play critical roles in TOrC metabolism. Finally, we identified previously undescribed degrading strains, e.g., Rhodococcus qingshengii for caffeine, carbamazepine, sulfamethoxazole, and ibuprofen biotransformation, and potential transformation enzymes, e.g., SDR family oxidoreductase targeting sulfamethoxazole and putative hypothetical proteins for caffeine, atenolol and gabapentin biotransformation. This study provides fundamental insights into naturally assembled low-complexity degrader communities that can help to identify and tackle the current research gaps on biotransformation.

52

News (Medical) associated with Gabapentin

09 Jan 2025

·www.drugs.com

Gabapentin Doesn't Increase Fall Risk, Study Suggests

THURSDAY, Jan. 9, 2025 -- A pain-relieving medication might be safer for seniors than first thought. A new study published Jan. 7 in the Annals of Internal Medicine says Gabapentin is widely used to help treat chronic pain and nerve pain, particularly as an alternative to opioid painkillers. However, some have argued that gabapentin shouldn’t be prescribed to seniors, as it might increase their risk of damaging falls . Those concerns are baseless, according to the study. The study’s results show that gabapentin “was associated with fewer fall-related health care visits and … was not associated with an increase in more severe fall-related events,” concluded a research team led by Dr. Alexander Chaitoff , an assistant professor of internal medicine with the University of Michigan. “These considerations should be incorporated into conversations with patients who are considering starting gabapentin treatment,” the team added. Nearly 50 million prescriptions for gabapentin were written in 2020, but by 2022 those scripts had fallen by 20% after several studies found that the drug might increase fall risk for seniors. Chaitoff and his colleagues suspected that this risk might be overblown, given that the painful conditions for which gabapentin is prescribed also increases risk of falls. “Neuropathy, the most common indication for which gabapentin is prescribed, is also a known contributor to adverse health events, especially falls,” the researchers noted. The researchers decided to compare the safety of gabapentin against that of duloxetine , another drug prescribed for nerve pain that doesn’t have the same reputation for increasing fall risk. The team gathered data for more than 57,000 seniors 65 or older prescribed either gabapentin or duloxetine between Jan. 2014 and Dec. 2021 for nerve pain related to diabetes , shingles or fibromyalgia. The results showed that gabapentin users actually had a 48% lower overall risk of any falls, compared to those taking duloxetine. However, there was no difference between the two drugs when it came to the risk of experiencing a severe fall. “Although we cannot claim that gabapentin does not lead to higher risk for falls at any time, our study does suggest that the risks of gabapentin as they relate to fall risk in the first 6 months of initiation are not greater, or potentially favorable, versus an alternative medication that might be prescribed instead,” the research team concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug Approval

07 Jan 2025

·www.drugs.com

Incident Gabapentin Use Not Linked to Increase in Falls Versus Duloxetine

TUESDAY, Jan. 7, 2025 -- Incident use of gabapentin is not associated with an increase in fall-related hospital visits compared with duloxetine use, according to a study published online Jan. 7 in the Annals of Internal Medicine . Alexander Chaitoff, M.D., M.P.H., from the University of Michigan School of Medicine in Ann Arbor, and colleagues describe the risk for fall-related outcomes in older adults with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia starting gabapentin versus duloxetine treatment. The analytic cohort included 57,086 older adults initiating treatment with gabapentin (52,152 adults) or duloxetine (4,934 adults). The researchers found that the weighted cumulative incidence rates of a fall-related visit at 30, 90, and 180 days were 103.60, 90.44, and 84.44 per 1,000 person-years, respectively, for gabapentin users and 203.43, 177.73, and 158.21 per 1,000 person-years, respectively, for duloxetine users. A lower hazard of falls was seen for incident gabapentin users at six-month follow-up (hazard ratio, 0.52), but no difference was seen in the risk for experiencing severe falls. Across sensitivity and subgroup analyses, the results were similar. "Incident gabapentin use, compared with incident duloxetine use, was associated with fewer fall-related health care visits and smaller differences in absolute measures and was not associated with an increase in more severe fall-related events," the authors write. "These considerations should be incorporated into conversations with patients who are considering starting gabapentin treatment."

Clinical Result

19 Dec 2024

·www.accesswire.com

MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development

MIAMI, FL / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.Erez Aminov, Chairman & CEO of Mira, stated: "This IND submission highlights our team's commitment to executing efficiently as we advance transformative therapies. Ketamir-2 not only has demonstrated remarkable potential for neuropathic pain but also offers a broad opportunity across other major neuropsychiatric conditions. We look forward to beginning Phase I trials and continuing to deliver on our mission to address unmet medical needs."The IND application includes comprehensive data and reports detailing Ketamir-2's pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models. In parallel with the submission, the company is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the pre-IND documentation.According to a market analysis report from Fortune Business Insights, the neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate (CAGR), reaching $4.5 billion by 2030. Despite this growth, existing treatments remain inadequate. Gabapentin and pregabalin, while widely prescribed, provide limited efficacy and are associated with side effects such as sedation, dizziness, and weight gain. Opioids remain a common treatment option but come with well-known risks of dependency, addiction, and respiratory depression. Intravenous ketamine, though effective for some patients, requires invasive administration and is often associated with psychotropic side effects, including hallucinations and dissociation.Ketamir-2 is specifically designed to address the limitations of existing treatments through its selective targeting of the NMDA receptor. By binding to a specific site on the NMDA receptor with low affinity, Ketamir-2 significantly reduces the risk of psychotropic effects commonly associated with traditional ketamine. Furthermore, it is not a substrate for P-glycoprotein (P-gp), which allows for better oral absorption and enhanced blood-brain barrier penetration. Unlike traditional ketamine, Ketamir-2 does not cause sedation or hyperactivity-side effects often linked to psychiatric conditions such as schizophrenia, bipolar mania, and ADHD. As a non-opioid therapy, Ketamir-2 is designed to eliminate the risks of dependency and addiction. Additionally, the DEA has determined that Ketamir-2 is not a controlled substance, streamlining accessibility and minimizing regulatory hurdles.Preclinical studies have demonstrated Ketamir-2's ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models. Furthermore, Ketamir-2 has shown a strong safety and toxicological profile, observed across cardiovascular, CNS, respiratory, or toxicology assessments.Dr. Itzchak Angel, Chief Scientific Advisor at Mira, commented: "Ketamir-2's selective mechanism of action, strong safety profile, and ability to achieve full pain reversal underscore its potential as a transformative therapy."With the IND submitted, MIRA expects to initiate Phase I Clinical Trials in Q1 2025 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Phase IIa trials are expected to follow in late 2025 to assess efficacy in neuropathic pain patients. Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including MDD, MDD-SI, TRD and PTSD.About MIRA Pharmaceuticals, Inc.MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com.Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2023, and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.Contact InformationHelga Moya [email protected](786) 432-9792SOURCE: Mira Pharmaceuticals, Inc.

Phase 1Phase 2IND

100 Deals associated with Gabapentin

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External Link

KEGG	Wiki	ATC	Drug Bank
D00332	Gabapentin	N03AX12	DB00996

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral neuralgia	DE	Viatris Pharma GmbH	27 Oct 2006
Neuralgia, Postherpetic	US	Viatris Specialty LLC	02 Mar 2000
Anxiety Disorders	JP	Pfizer Inc.	30 Dec 1993
Cough	JP	Pfizer Inc.	30 Dec 1993
Diabetic Neuropathies	JP	Pfizer Inc.	30 Dec 1993
Epilepsies, Partial	US	Viatris Specialty LLC	30 Dec 1993
Epilepsy	US	Viatris Specialty LLC	30 Dec 1993
Fibromyalgia	JP	Pfizer Inc.	30 Dec 1993
Restless Legs Syndrome	JP	Pfizer Inc.	30 Dec 1993
Seizures	JP	Pfizer Inc.	30 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tremor	Phase 2	US	Pfizer Inc.	01 Mar 2004
Refractory chronic cough	Discovery	AU	Hunter New England Area Health Service	15 Oct 2008
Hot Flashes	Discovery	US	Assertio Therapeutics, Inc.	01 Sep 2008
Vasomotor symptom	Discovery	US	Assertio Therapeutics, Inc.	01 Sep 2008
Epilepsies, Partial	Discovery	JP	Viatris, Inc.	01 Jan 2008
Seizures	Discovery	JP	Viatris, Inc.	01 Jan 2008
Neuralgia, Postherpetic	Discovery	US	Assertio Therapeutics, Inc.	01 May 2006
Sleep Initiation and Maintenance Disorders	Discovery	US	Viatris, Inc.	01 Oct 2004
Carpal Tunnel Syndrome	Discovery	HK	Pfizer Inc.	01 Oct 2003
Amyotrophic Lateral Sclerosis	Discovery	US	Pfizer Inc.	31 Dec 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	wzhhlwtrtj(svlfjjqhsd) = etychwszje uiwzfurkyj (paanvazjik, vvbwghppsd - huudkpeukc) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	wzhhlwtrtj(svlfjjqhsd) = ufsqxaufsi uiwzfurkyj (paanvazjik, iztmefascf - qrkqyuantv) View more
NCT01678586 (CTgov)	Not Applicable	Radicular Pain	56	acupuncture (True Acupuncture)	jkcunfupcd(mhylkedtsu) = byefinyzbz rkqaghzekq (lugwffsses, vbxrtwigoo - ftgefbhlzz) View more	-	23 Apr 2024
				Sham acupuncture (Sham Acupuncture)	jkcunfupcd(mhylkedtsu) = ljkffdffrw rkqaghzekq (lugwffsses, rmplnxvpdz - dejtzygmrp) View more
NCT03818919 (CTgov)	Phase 2	Analgesia \| Rotator Cuff Tear Arthropathy	70	Acetaminophen+Diazepam+Ketorolac+Celecoxib+Gabapentin (Post-Operative Non Opioid Pain Protocol)	efrhemkwzn(gfsqrmaoho) = avdpbcrhxy oiyjmwzibe (ltoizimpzu, bzhpsbvpkj - gqqtxauocc) View more	-	02 Apr 2024
				Hydrocodone-Acetaminophen (Post-Operative Traditional Pain Protocol)	efrhemkwzn(gfsqrmaoho) = ommscgksdw oiyjmwzibe (ltoizimpzu, hzobvvwnoe - okelqryskk) View more
NCT05172570 (CTgov)	Phase 3	Pain, Postoperative	20	gabapentin (No Gabapentin)	ctndbhmtxq(lwxehigghv) = gnbkssajfk ikonbkkqbr (lstihzrtdk, fmxixfjxyb - enfbbtxgts) View more	-	21 Mar 2024
				gabapentin (300 mg Gabapentin 3X Per Day)	ctndbhmtxq(lwxehigghv) = zhigeiyjvg ikonbkkqbr (lstihzrtdk, erxnfniicj - qqfxygeunx) View more
NCT04570436 (CTgov)	Phase 4	Sedative abuse	52	placebo (Placebo)	temymqynti(jpswwnijyg) = mdgqaujjfc pigwkcridi (hazyhdwxyx, fgkwxqgthd - usnrooxihv) View more	-	06 Dec 2023
				diazepam 20 mg (Diazepam 20 mg)	temymqynti(jpswwnijyg) = nhfcjtjjxr pigwkcridi (hazyhdwxyx, qfyeuttnvb - wvbpvvgvip) View more
NCT04230980 (CTgov)	Phase 3	Azoospermia, Nonobstructive \| Pain, Postoperative	74	Gabapentin (Gabapentin)	uroevakdql(jpzgcphjzo) = ssyluipgmg alyaxhvpju (tlsssrgyec, oyawbunvdo - vpcncqclca) View more	-	18 Oct 2023
				Placebo (Placebo)	uroevakdql(jpzgcphjzo) = kxyuajjbdx alyaxhvpju (tlsssrgyec, thuiydrbal - qvnowejrzz) View more
NCT04429022 (RA-TLH, CTgov)	Phase 3	Pain, Postoperative	68	Local anesthetic injection+Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites+Hydromorphone+Acetaminophen+Ketorolac+Celecoxib+Oxycodone+Gabapentin (Prospective Cohort)	epatvabogz(ukahqqzobi) = kuynzeyapn patdfagfar (aksvwegswg, jfbjlmsexg - xqgawokbsp) View more	-	01 Aug 2023
				Hydromorphone (Historical Control)	epatvabogz(ukahqqzobi) = wceftkvfin patdfagfar (aksvwegswg, mewjdtpudc - rjmdwjhqql) View more
WCD2023	Not Applicable	Flushing	318	Gabapentin 200 mg bid	(jtintpootn) = fnwnqmzvhe quewenukjl (vtcucxxgfe )	-	03 Jul 2023
				Gabapentin 400 mg tid	(jtintpootn) = yiiblsicwr quewenukjl (vtcucxxgfe )
NCT04766229 (ASCO2023) Manual	Phase 2	Vasomotor symptom Adjuvant	205	citalopram +/- gabapentingabapentin+digital cognitive behavioural therapy+self-management strategies+support person/partner nomination (intention to treat (ITT) cohort)	(poalovryld) = In the ITT cohort mean QoL scores increased from 62.2 (SEM 1.4) at baseline to 70.4 (SEM 1.7) at 6 months (p < 0.001). In the PP cohort, mean QoL scores increased from 62 (SEM 1.7) to 70.4 (SEM 1.7) at 6 months (p < 0.001). Clinically meaningful improvements were seen across multiple domains of the EORTC QLQ C30 including cognitive function, emotional function and social functioning. yzfspenidv (ulfpzoelml ) View more	Positive	31 May 2023
				citalopram +/- gabapentingabapentin+digital cognitive behavioural therapy+self-management strategies+support person/partner nomination (per protocol (PP) cohort)