Landmark Psychiatric Research Studies and Papers

There are many landmark psychiatric studies in psychiatry that clinicians should be aware of. Key studies are listed below (work in progress).

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STAR*D (Sequenced Treatment Alternatives to Relieve Depression) was an NIMH study that compared the effectiveness of various antidepressants. STAR*D was actually a multi-level study, with 4 levels. In Level 1 of STAR*D, patients with major depressive disorder were treated on citalopram. Remission and response rates, treatment length, and features associated with remission were investigated. comorbidities.

STAR*D (Level 1) Design

Design Open-label, pragmatic
Year 2006
Sample size N = 2876
Population Ages 18-75, non-psychotic major depressive disorder (Hamilton Depression Rating Scale [HAM-D] ≥14)
Sites/Locations Clinical sites across the United States providing primary or psychiatric care.
Allocation All patients received citalopram (open label), with no placebo control
Follow up Up to 14 weeks
Primary outcome Remission (HAM-D ≤7)
Secondary outcomes Remission (Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR]≤5), or response (QIDS-SR reduction of ≥50% in baseline score).

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) was an NIMH study designed to compare the effectiveness of antipsychotic drugs in adults with schizophrenia in the United States.

CATIE Study Design

Design Randomized Controlled Trial
Year 2005
Sample size N=1,493
Population Adults with schizophrenia, ages 18-65
Sites/Locations 57 sites in the United States
Allocation Participants were randomly assigned to receive 1 of 5 antipsychotics: olanzapine, perphenazine, quetiapine, risperidone, and ziprasidone.
Follow up Patients were followed for 18 months or until treatment was discontinued
Primary outcome Discontinuation of treatment for any cause
Secondary outcomes Inefficacy, intolerability due to weight gain, extrapyramidal side effects, sedation, Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions (CGI) Scale.
Key Findings
  • Rates of discontinuation were high for all antipsychotics (64%-82%)
  • Risperidone was significantly associated with hyperprolactinemia
  • Patients on olanzapine experienced a longer time to discontinuation (i.e. - stayed on it the longest), but they also had greater weight gain, hyperglycemia, and hyperlipidemia (compared to every other antipsychotic in the trial)

The National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program (TDCRP) was a multisite RCT that compared medication, CBT, IPT, pharmacotherapy with clinical management, and clinical management alone. High baseline depression severity in patients showed that those receiving medication did best followed by patients receiving IPT which outperformed CBT in this study