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1.  The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial 
Trials  2014;15(1):425.
Background
The aim of the Youth Depression Alleviation–Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.
Methods/Design
YoDA-C is a double-blind, randomised controlled trial funded by the Australian government’s National Health and Medical Research Council. Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either (1) cognitive behavioural therapy (CBT) and fluoxetine or (2) CBT and placebo. The treatment duration will be 12 weeks, and follow-up will be conducted at 26 weeks. The primary outcome measure is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 12 weeks of treatment. The MADRS will be administered at baseline and at weeks 4, 8, 12 and 26. Secondary outcome measures will address additional clinical outcomes, functioning, quality of life and safety.
Trial registration
Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012)
doi:10.1186/1745-6215-15-425
PMCID: PMC4230740  PMID: 25370185
Adolescence; Antidepressants; Cognitive behavioural therapy; Depression; Fluoxetine; Selective serotonin reuptake inhibitors; Youth
2.  A Randomized Controlled Trial of Bibliotherapy for Carers of Young People With First-Episode Psychosis 
Schizophrenia Bulletin  2012;39(6):1307-1317.
Caring for young people with first-episode psychosis (FEP) is challenging and can adversely affect carer well-being, with limited evidence-based support materials available. We aimed to examine whether completion of a self-directed problem-solving bibliotherapy among carers of young people with FEP led to a better experience of caring, less distress and expressed emotion, and better general health than carers who only received treatment as usual (TAU). A randomized controlled trial was conducted across two early-intervention psychosis services in Melbourne, Australia. A total of 124 carers were randomized to problem-solving bibliotherapy intervention (PSBI) or TAU and assessed at baseline, 6-week and 16-week follow-up. Intent-to-treat analyses were carried out and indicated that recipients of PSBI had a more favorable experience of caring than those receiving TAU, and these effects were sustained at both follow-up time points. Across the other measures, both groups demonstrated improvements by week 16, although the PBSI group tended to improve earlier. The PSBI group experienced a greater reduction in negative emotional evaluations of the need to provide additional support to young people with FEP than the TAU group by week 6, while the level of psychological distress decreased at a greater rate from baseline to 6 weeks in the PSBI compared with the TAU group. These findings support the use of problem-solving bibliotherapy for first-time carers, particularly as a cost-effective adjunct to TAU.
doi:10.1093/schbul/sbs121
PMCID: PMC3796072  PMID: 23172001
burden; experience of caregiving; expressed emotion; problem-solving; self-help
3.  A Randomized Controlled Trial of Relapse Prevention Therapy for First-Episode Psychosis Patients: Outcome at 30-Month Follow-Up 
Schizophrenia Bulletin  2011;39(2):436-448.
The effectiveness of a novel 7-month psychosocial treatment designed to prevent the second episode of psychosis was evaluated in a randomized controlled trial at 2 specialist first-episode psychosis (FEP) programs. An individual and family cognitive behavior therapy for relapse prevention was compared with specialist FEP care. Forty-one FEP patients were randomized to the relapse prevention therapy (RPT) and 40 to specialist FEP care. Participants were assessed on an array of measures at baseline, 7- (end of therapy), 12-, 18-, 24-, and 30-month follow-up. At 12-month follow-up, the relapse rate was significantly lower in the therapy condition compared with specialized treatment alone (P = .039), and time to relapse was significantly delayed for those in the relapse therapy condition (P = .038); however, such differences were not maintained. Unexpectedly, psychosocial functioning deteriorated over time in the experimental but not in the control group; these differences were no longer statistically significant when between-group differences in medication adherence were included in the model. Further research is required to ascertain if the initial treatment effect of the RPT can be sustained. Further research is needed to investigate if medication adherence contributes to negative outcomes in functioning in FEP patients who have reached remission, or, alternatively, if a component of RPT is detrimental.
doi:10.1093/schbul/sbr165
PMCID: PMC3576162  PMID: 22130905
first-episode psychosis; early psychosis; relapse prevention; randomized controlled trials
4.  Gender differences in first episode psychotic mania 
BMC Psychiatry  2013;13:82.
Background
The aim of this paper was to delineate the impact of gender on premorbid history, onset, and 18 month outcomes of first episode psychotic mania (FEPM) patients.
Methods
Medical file audit assessment of 118 (male = 71; female = 47) patients with FEPM aged 15 to 29 years was undertaken on clinical and functional measures.
Results
Males with FEPM had increased likelihood of substance use (OR = 13.41, p <.001) and forensic issues (OR = 4.71, p = .008), whereas females were more likely to have history of sexual abuse trauma (OR = 7.12, p = .001). At service entry, males were more likely to be using substances, especially cannabis (OR = 2.15, p = .047), had more severe illness (OR = 1.72, p = .037), and poorer functioning (OR = 0.96, p = .045). During treatment males were more likely to decrease substance use (OR = 5.34, p = .008) and were more likely to be living with family (OR = 4.30, p = .009). There were no gender differences in age of onset, psychopathology or functioning at discharge.
Conclusions
Clinically meaningful gender differences in FEPM were driven by risk factors possibly associated with poor outcome. For males, substance use might be associated with poorer clinical presentation and functioning. In females with FEPM, the impact of sexual trauma on illness course warrants further consideration.
doi:10.1186/1471-244X-13-82
PMCID: PMC3602146  PMID: 23497439
Gender; Mania; Psychosis; Bipolar disorder
5.  The Impact of Cannabis Use on Cognitive Functioning in Patients With Schizophrenia: A Meta-analysis of Existing Findings and New Data in a First-Episode Sample 
Schizophrenia Bulletin  2010;38(2):316-330.
Cannabis use is highly prevalent among people with schizophrenia, and coupled with impaired cognition, is thought to heighten the risk of illness onset. However, while heavy cannabis use has been associated with cognitive deficits in long-term users, studies among patients with schizophrenia have been contradictory. This article consists of 2 studies. In Study I, a meta-analysis of 10 studies comprising 572 patients with established schizophrenia (with and without comorbid cannabis use) was conducted. Patients with a history of cannabis use were found to have superior neuropsychological functioning. This finding was largely driven by studies that included patients with a lifetime history of cannabis use rather than current or recent use. In Study II, we examined the neuropsychological performance of 85 patients with first-episode psychosis (FEP) and 43 healthy nonusing controls. Relative to controls, FEP patients with a history of cannabis use (FEP + CANN; n = 59) displayed only selective neuropsychological impairments while those without a history (FEP − CANN; n = 26) displayed generalized deficits. When directly compared, FEP + CANN patients performed better on tests of visual memory, working memory, and executive functioning. Patients with early onset cannabis use had less neuropsychological impairment than patients with later onset use. Together, these findings suggest that patients with schizophrenia or FEP with a history of cannabis use have superior neuropsychological functioning compared with nonusing patients. This association between better cognitive performance and cannabis use in schizophrenia may be driven by a subgroup of “neurocognitively less impaired” patients, who only developed psychosis after a relatively early initiation into cannabis use.
doi:10.1093/schbul/sbq079
PMCID: PMC3283159  PMID: 20660494
schizophrenia; psychosis; marijuana; drug; neuropsychology; comorbidity
6.  Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial 
BMC Medicine  2012;10:91.
Background
N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder.
Method
The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes.
Results
There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures.
Conclusions
There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations.
Trial Registration
The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).
doi:10.1186/1741-7015-10-91
PMCID: PMC3482580  PMID: 22891797
N-acetyl cysteine; depression; bipolar disorder; maintenance; mania; oxidative
7.  A factor analytic investigation of the Tripartite model of affect in a clinical sample of young Australians 
BMC Psychiatry  2008;8:79.
Background
The Mood and Anxiety Symptom Questionnaire (MASQ) was designed to specifically measure the Tripartite model of affect and is proposed to offer a delineation between the core components of anxiety and depression. Factor analytic data from adult clinical samples has shown mixed results; however no studies employing confirmatory factor analysis (CFA) have supported the predicted structure of distinct Depression, Anxiety and General Distress factors. The Tripartite model has not been validated in a clinical sample of older adolescents and young adults. The aim of the present study was to examine the validity of the Tripartite model using scale-level data from the MASQ and correlational and confirmatory factor analysis techniques.
Methods
137 young people (M = 17.78, SD = 2.63) referred to a specialist mental health service for adolescents and young adults completed the MASQ and diagnostic interview.
Results
All MASQ scales were highly inter-correlated, with the lowest correlation between the depression- and anxiety-specific scales (r = .59). This pattern of correlations was observed for all participants rating for an Axis-I disorder but not for participants without a current disorder (r = .18). Confirmatory factor analyses were conducted to evaluate the model fit of a number of solutions. The predicted Tripartite structure was not supported. A 2-factor model demonstrated superior model fit and parsimony compared to 1- or 3-factor models. These broad factors represented Depression and Anxiety and were highly correlated (r = .88).
Conclusion
The present data lend support to the notion that the Tripartite model does not adequately explain the relationship between anxiety and depression in all clinical populations. Indeed, in the present study this model was found to be inappropriate for a help-seeking community sample of older adolescents and young adults.
doi:10.1186/1471-244X-8-79
PMCID: PMC2561028  PMID: 18799017
8.  Psychotic-Like Experiences in Nonpsychotic Help-Seekers: Associations With Distress, Depression, and Disability 
Schizophrenia Bulletin  2005;32(2):352-359.
Psychotic-like experiences (PLEs) increase the risk of schizophrenia and other psychotic disorders yet are common in the community. Some PLEs, such as those associated with depression, distress, and poor functioning, may confer increased risk. The aim of this study is to determine the prevalence of PLEs in a nonpsychotic clinical sample and to investigate whether any subtypes of PLEs are associated with the above factors. Consecutive referrals to a youth psychiatric service (N = 140) were assessed to measure PLEs, depression, and functioning. PLE data were factor analyzed, and the associations of psychotic subtypes and distress, depression, and disability were analyzed. Three subtypes of PLEs were identified: Bizarre Experiences, Persecutory Ideas, and Magical Thinking. Bizarre Experiences and Persecutory Ideas were associated with distress, depression, and poor functioning. Magical Thinking was not, unless accompanied by distress. Bizarre Experiences and Persecutory Ideas may be more malignant forms of psychotic symptoms, as they are associated with current disability, and may confer increased risk of development of full-blown psychotic disorder.
doi:10.1093/schbul/sbj018
PMCID: PMC2632224  PMID: 16254060
schizophrenia; psychosis; risk

Results 1-8 (8)