Melanie Lean, Clin.Psych.D. is a Californian licensed clinical psychologist, Clinical Assistant Professor, and assistant director of research in the INSPIRE early psychosis clinic, Stanford University School of Medicine. She provides Cognitive Behavioral Therapy for psychosis (CBTp) within the recovery oriented and trauma informed framework of the INSPIRE clinic. Dr Lean received her doctorate from University College London, UK and completed her postdoctoral fellowship at Stanford University. She is a mixed methods researcher, with over 15 years’ experience in mental health research, working across a range of settings with a focus on severe and enduring mental illness and ways to improve service provision for this population. She has specialized knowledge in self-management and peer support interventions for people with psychosis and has experience working alongside service user researchers in the evaluation and delivery of study interventions. Dr Lean is also trained in psychedelic assisted therapy and works on a range of clinical trials investigating psilocybin for treatment resistant depression.

Clinical Focus

  • Clinical Psychology
  • Early Intervention for Psychosis
  • Women's Wellness
  • Women's Sexual Dysfunction
  • Vaginismus and Pelvic pain

Academic Appointments

  • Clinical Assistant Professor, Psychiatry and Behavioral Sciences

Professional Education

  • Professional Education: University College London (2017) UK
  • DClinPsy, University College London (UCL), Clinical Psychology (2017)

Clinical Trials

  • A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia Recruiting

    This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.

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  • Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD Recruiting

    Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)

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  • Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia Recruiting

    The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.

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  • California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis Not Recruiting

    The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be tested via development and validation of a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings. The proposed California network will contribute systematically collected outcomes data on over 100 FEP clients per year, from 12 community and university EP clinics, to enhance the development of a national EP network, supported by the NIMH EPINET program.

    Stanford is currently not accepting patients for this trial.

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  • CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia Not Recruiting

    This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.

    Stanford is currently not accepting patients for this trial. For more information, please contact Daniel Virtheim, (650) 353-7030.

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  • Improving Cognition Via Exercise in Schizophrenia Not Recruiting

    People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functioning and disability. Also, people with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime. The goal of the proposed study is to examine the impact of remote exercise training on cognition, suicide risk, daily functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.

    Stanford is currently not accepting patients for this trial. For more information, please contact Daniel Virtheim, 650-353-7030.

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  • Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia Not Recruiting

    Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.

    Stanford is currently not accepting patients for this trial. For more information, please contact Diane Wakeham, (650) 736- 5243.

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All Publications

  • An open label study of the safety and efficacy of psilocybin in veterans with severe treatment-resistant depression Ellis, S., Suppes, T., Fischer, E., Feng, W., Eisen, K., Lean, M., Conlan, B., Lyu, J., Ostacher, M., Aaronson, S. WILEY. 2023: 90
  • Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. The New England journal of medicine Goodwin, G. M., Aaronson, S. T., Alvarez, O., Arden, P. C., Baker, A., Bennett, J. C., Bird, C., Blom, R. E., Brennan, C., Brusch, D., Burke, L., Campbell-Coker, K., Carhart-Harris, R., Cattell, J., Daniel, A., DeBattista, C., Dunlop, B. W., Eisen, K., Feifel, D., Forbes, M., Haumann, H. M., Hellerstein, D. J., Hoppe, A. I., Husain, M. I., Jelen, L. A., Kamphuis, J., Kawasaki, J., Kelly, J. R., Key, R. E., Kishon, R., Knatz Peck, S., Knight, G., Koolen, M. H., Lean, M., Licht, R. W., Maples-Keller, J. L., Mars, J., Marwood, L., McElhiney, M. C., Miller, T. L., Mirow, A., Mistry, S., Mletzko-Crowe, T., Modlin, L. N., Nielsen, R. E., Nielson, E. M., Offerhaus, S. R., O'Keane, V., Páleníček, T., Printz, D., Rademaker, M. C., van Reemst, A., Reinholdt, F., Repantis, D., Rucker, J., Rudow, S., Ruffell, S., Rush, A. J., Schoevers, R. A., Seynaeve, M., Shao, S., Soares, J. C., Somers, M., Stansfield, S. C., Sterling, D., Strockis, A., Tsai, J., Visser, L., Wahba, M., Williams, S., Young, A. H., Ywema, P., Zisook, S., Malievskaia, E. 2022; 387 (18): 1637-1648


    Psilocybin is being studied for use in treatment-resistant depression.In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits).A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P<0.001) and between the 10-mg group and 1-mg group was -2.5 (95% CI, -6.2 to 1.2; P = 0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups.In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; number, NCT03775200.).

    View details for DOI 10.1056/NEJMoa2206443

    View details for PubMedID 36322843

  • Training inpatient psychiatric nurses and staff to utilize CBTp informed skills in an acute inpatient psychiatric setting PSYCHOSIS-PSYCHOLOGICAL SOCIAL AND INTEGRATIVE APPROACHES Eisen, K., Kharrazi, N., Simonson, A., Lean, M., Hardy, K. 2021
  • Pilot study of a group worry intervention for recent onset psychosis COGNITIVE BEHAVIOUR THERAPIST Mackintosh, T., Lean, M., Hardy, K. 2021; 14
  • Training early psychosis community clinicians in CBT for psychosis: Implementation and feasibility. Early intervention in psychiatry Hardy, K. V., Espil, F. M., Smith, C. L., Furuzawa, A., Lean, M., Zhao, Z., Godzikovskaya, J., Gilbert, A., Loewy, R. L. 2020


    OBJECTIVE: Cognitive behavioural therapy (CBT) has demonstrated efficacy for treating of psychotic symptoms and is recommended as an evidence-based practice (EBP) in early psychosis services. Despite this recommendation, there is limited information about the feasibility of training community clinicians, working in an early psychosis service, to competence in the delivery of this intervention.METHOD: Fifty clinicians working in an early psychosis service across five programs in Northern California were trained in CBT for psychosis (CBTp) between 2010 and 2014. Following the training, clinicians attended weekly group consultation and submitted taped sessions for review. Tapes were rated for competency using the Cognitive Therapy Scale-Revised (CTS-R). Clinicians who achieved competence were engaged in a train-the-trainer model to support ongoing sustainability of the training program.RESULTS: Data from 40 clinicians were reviewed for achievement of competence. Over the training period 18 clinicians achieved competence while 20 clinicians left the service before achieving competence and 12 were still in the process of achieving competence at the point of data analysis. It took on average 54weeks (range 17-130weeks) and an average of six tape reviews (range 3-18) to train clinicians to competency.CONCLUSIONS: Community clinicians working in an early psychosis program can be trained to competence in CBTp following an initial didactic period and ongoing weekly group consultation, although staff turnover hindered implementation. Challenges and opportunities for future implementation in community sites are presented in the context of further expansion of early psychosis services in the United States.

    View details for DOI 10.1111/eip.13010

    View details for PubMedID 32583602

  • Self-management interventions for people with severe mental illness: systematic review and meta-analysis BRITISH JOURNAL OF PSYCHIATRY Lean, M., Fornells-Ambrojo, M., Milton, A., Lloyd-Evans, B., Harrison-Stewart, B., Yesufu-Udechuku, A., Kendall, T., Johnson, S. 2019; 214 (5): 260–68


    Self-management is intended to empower individuals in their recovery by providing the skills and confidence they need to take active steps in recognising and managing their own health problems. Evidence supports such interventions in a range of long-term physical health conditions, but a recent systematic synthesis is not available for people with severe mental health problems.AimsTo evaluate the effectiveness of self-management interventions for adults with severe mental illness (SMI).A systematic review of randomised controlled trials was conducted. A meta-analysis of symptomatic, relapse, recovery, functioning and quality of life outcomes was conducted, using RevMan.A total of 37 trials were included with 5790 participants. From the meta-analysis, self-management interventions conferred benefits in terms of reducing symptoms and length of admission, and improving functioning and quality of life both at the end of treatment and at follow-up. Overall the effect size was small to medium. The evidence for self-management interventions on readmissions was mixed. However, self-management did have a significant effect compared with control on subjective measures of recovery such as hope and empowerment at follow-up, and self-rated recovery and self-efficacy at both time points.There is evidence that the provision of self-management interventions alongside standard care improves outcomes for people with SMI. Self-management interventions should form part of the standard package of care provided to people with SMI and should be prioritised in guidelines: research on best methods of implementing such interventions in routine practice is needed.Declaration of interestsNone.

    View details for DOI 10.1192/bjp.2019.54

    View details for Web of Science ID 000465581400004

    View details for PubMedID 30898177

    View details for PubMedCentralID PMC6499726

  • Recovery-based staff training intervention within mental health rehabilitation units: a two-stage analysis using realistic evaluation principles and framework approach BMC PSYCHIATRY Bhanbhro, S., Gee, M., Cook, S., Marston, L., Lean, M., Killaspy, H. 2016; 16: 292


    Long-term change in recovery-based practice in mental health rehabilitation is a research priority.We used a qualitative case study analysis using a blend of traditional 'framework' analysis and 'realist' approaches to carry out an evaluation of a recovery-focused staff training intervention within three purposively selected mental health rehabilitation units. We maximised the validity of the data by triangulating multiple data sources.We found that organisational culture and embedding of a change management programme in routine practice were reported as key influences in sustaining change in practice. The qualitative study generated 10 recommendations on how to achieve long-term change in practice including addressing pre-existing organisational issues and synergising concurrent change programmes.We propose that a recovery-focused staff training intervention requires clear leadership and integration with any existing change management programmes to facilitate sustained improvements in routine practice.

    View details for DOI 10.1186/s12888-016-0999-y

    View details for Web of Science ID 000382228200001

    View details for PubMedID 27535830

    View details for PubMedCentralID PMC4989510

  • Clinical outcomes and costs for people with complex psychosis; a naturalistic prospective cohort study of mental health rehabilitation service users in England BMC PSYCHIATRY Killaspy, H., Marston, L., Green, N., Harrison, I., Lean, M., Holloway, F., Craig, T., Leavey, G., Arbuthnott, M., Koeser, L., McCrone, P., Omar, R. Z., King, M. 2016; 16: 95


    Mental health rehabilitation services in England focus on people with complex psychosis. This group tend to have lengthy hospital admissions due to the severity of their problems and, despite representing only 10-20 % of all those with psychosis, they absorb 25-50 % of the total mental health budget. Few studies have investigated the effectiveness of these services and there is little evidence available to guide clinicians working in this area. As part of a programme of research into inpatient mental health rehabilitation services, we carried out a prospective study to investigate longitudinal outcomes and costs for patients of these services and the predictors of better outcome.Inpatient mental health rehabilitation services across England that scored above average (median) on a standardised quality assessment tool used in a previous national survey were eligible for the study. Unit quality was reassessed and costs of care and patient characteristics rated using standardised tools at recruitment. Multivariable regression modelling was used to investigate the relationship between service quality, patient characteristics and the following clinical outcomes at 12 month follow-up: social function; length of admission in the rehabiliation unit; successful community discharge (without readmission or community placement breakdown) and costs of care.Across England, 50 units participated and 329 patients were followed over 12 months (94 % of those recruited). Service quality was not associated with patients' social function or length of admission (median 16 months) at 12 months but most patients were successfully discharged (56 %) or ready for discharge (14 %), with associated reductions in the costs of care. Factors associated with successful discharge were the recovery orientation of the service (OR 1.04, 95 % CI 1.00-1.08), and patients' activity (OR 1.03, 95 % CI 1.01-1.05) and social skills (OR 1.13, 95 % CI 1.04-1.24) at recruitment.Inpatient mental health rehabilitation services in England are able to successfully discharge over half their patients within 18 months, reducing the costs of care for this complex group. Provision of recovery orientated practice that promotes patients' social skills and activities may further enhance the effectiveness of these services.

    View details for DOI 10.1186/s12888-016-0797-6

    View details for Web of Science ID 000373605500001

    View details for PubMedID 27056042

    View details for PubMedCentralID PMC4823891

  • Barriers to the sustainability of an intervention designed to improve patient engagement within NHS mental health rehabilitation units: a qualitative study nested within a randomised controlled trial BMC PSYCHIATRY Lean, M., Leavey, G., Killaspy, H., Green, N., Harrison, I., Cook, S., Craig, T., Holloway, F., Arbuthnott, M., King, M. 2015; 15: 209


    We undertook a cluster randomised controlled trial to assess the effectiveness of a staff training intervention to improve patient engagement in activities in inpatient mental health rehabilitation units. Concurrently, we undertook a qualitative study to investigate the experiences of staff within the intervention units and the contextual issues that may have influenced the effectiveness of the intervention.We conducted focus groups with staff working in the inpatient units that received the intervention, sampled using a maximum variation strategy.The intervention was accepted by staff. However, the skills gained, and changes to the unit's processes and structures that were agreed with the intervention team were not sustained after they left. The main reasons for this were a) external factors (economic recession, resource limitations); b) organisation level factors (lack of senior staff support; competing priorities); c) limitations of the intervention itself (length of intensive training period; reinforcement of skills).This study illustrates some of the inter-related factors which operate at different levels within and outside of NHS organisations that may impact on the success of complex interventions. These factors need to be considered when designing interventions to ensure adequate buy-in from senior staff.Current Controlled Trials ISRCTN25898179 (Registered 23 April 2010).

    View details for DOI 10.1186/s12888-015-0592-9

    View details for Web of Science ID 000360340600001

    View details for PubMedID 26328771

    View details for PubMedCentralID PMC4556020

  • Clinical effectiveness of a staff training intervention in mental health inpatient rehabilitation units designed to increase patients' engagement in activities (the Rehabilitation Effectiveness for Activities for Life [REAL] study): single-blind, cluster-randomised controlled trial LANCET PSYCHIATRY Killaspy, H., Marston, L., Green, N., Harrison, I., Lean, M., Cook, S., Mundy, T., Craig, T., Holloway, F., Leavey, G., Koeser, L., McCrone, P., Arbuthnott, M., Omar, R. Z., King, M. 2015; 2 (1): 38-48


    Mental health inpatient rehabilitation services focus on people with complex psychosis who have, for example, treatment-refractory symptoms, cognitive impairment, and severe negative symptoms, which impair functioning and require lengthy admission. Engagement in activities could lead to improvement in negative symptoms and function, but few trials have been done. We aimed to investigate the effectiveness of a staff training intervention to increase patients' engagement in activities.We did a single-blind, two-arm, cluster-randomised controlled trial in 40 mental health inpatient rehabilitation units across England. Units were randomly allocated to either a manual-based staff training programme delivered by a small intervention team (intervention group, n=20) or standard care (control group, n=20). The primary outcome was patients' engagement in activities 12 months after randomisation, measured with the time use diary. With this measure, both the degree of engagement in an activity and its complexity are recorded four times a day for a week, rated on a scale of 0-4 for every period (maximum score of 112). Analysis was by intention-to-treat. Random-effects models were used to compare outcomes between study groups. Cost-effectiveness was assessed by combining service costs with the primary outcome. This study is registered with Current Controlled Trials (ISRCTN25898179).Patients' engagement in activities did not differ between study groups (coefficient 1·44, 95% CI -1·35 to 4·24). An extra £101 was needed to achieve a 1% increase in patients' engagement in activities with the study intervention.Our training intervention did not increase patients' engagement in activities after 12 months of follow-up. This failure could be attributable to inadequate implementation of the intervention, a high turnover of patients in the intervention units, competing priorities on staff time, high levels of patients' morbidity, and ceiling effects because of the high quality of standard care delivered. Further studies are needed to identify interventions that can improve outcomes for people with severe and complex psychosis.National Institute for Health Research.

    View details for DOI 10.1016/S2215-0366(14)00050-9

    View details for Web of Science ID 000352705600023

    View details for PubMedID 26359611

  • Link between outcome and service quality is not clear reply BRITISH JOURNAL OF PSYCHIATRY Killaspy, H., Marston, L., Omar, R. Z., Green, N., Harrison, I., Lean, M., Holloway, F., Craig, T., Leavey, G., King, M. 2013; 202 (4): 309

    View details for DOI 10.1192/bjp.202.4.309a

    View details for Web of Science ID 000317702300015

    View details for PubMedID 23549945

  • Service quality and clinical outcomes: an example from mental health rehabilitation services in England BRITISH JOURNAL OF PSYCHIATRY Killaspy, H., Marston, L., Omar, R. Z., Green, N., Harrison, I., Lean, M., Holloway, F., Craig, T., Leavey, G., King, M. 2013; 202 (1): 28-34


    Current health policy assumes better quality services lead to better outcomes.To investigate the relationship between quality of mental health rehabilitation services in England, local deprivation, service user characteristics and clinical outcomes.Standardised tools were used to assess the quality of mental health rehabilitation units and service users' autonomy, quality of life, experiences of care and ratings of the therapeutic milieu. Multiple level modelling investigated relationships between service quality, service user characteristics and outcomes.A total of 52/60 (87%) National Health Service trusts participated, comprising 133 units and 739 service users. All aspects of service quality were positively associated with service users' autonomy, experiences of care and therapeutic milieu, but there was no association with quality of life.Quality of care is linked to better clinical outcomes in people with complex and longer-term mental health problems. Thus, investing in quality is likely to show real clinical gains.

    View details for DOI 10.1192/bjp.bp.112.114421

    View details for Web of Science ID 000315745000008

    View details for PubMedID 23060623