Naturalistic study

For some mental health problems such as severe dementia, effectiveness might actually be achieved by slowing down a deteriorative trend or accelerating an upward trend. This makes effectiveness difficult to assess without a control or comparison group, or a set of norms, and emphasizes why naturalistic studies alone are rarely sufficient as an evidence base for clinical or policy decisions. 

With few exceptions, models find in favour of newer compounds Qonsson and Bebbington, 1994 Le Pen et al, 1994 McFarland, 1994 Stewart, 1994 Einarson et al, 1995 Lapierre et al, 1995 Nuitjen et al, 1995 Montgomeiy et al, 1996). One study (CCOHTA, 1997) did make allowances for variations in practice and patient behaviour. The results indicated that in the short term treatment was likely to be more successful with an SSRI than with a TCA, but at a higher cost. However, when treatment dropout rates found in naturalistic studies were substituted for drop-out rates found in controlled trials, the cost differences became smaller. When cost-utility analysis was applied, this increased cost was offset by improvements in quality of life for the patients. 

Naturalistic studies reveal that in primary care, the suboptimal use of antidepressants appears to be an almost universal practice worldwide. Patients treated with TCAs are... 

Another approach uses a synthesis of RCTs and naturalistic studies, while addressing the limitations of both (Simon et al, 1995b Hotopf et al, 1996). In such studies the treatment setting is routine primary-care clinical practice selection criteria are limited to those affecting safety and treatment is normal , i.e. provided under conditions where differences in clinical practice and patient behaviour can emerge freely. However, participants are randomized to initial treatment, and accurate diagnosis and baseline assessments are recorded. This approach is... 

It is essential that research to assess the cost-effectiveness of antidepressant pharmacotherapy continues and that better pharmacoeconomic research methods evolve. Naturalistic studies may be used to observe how antidepressant dmgs petform in practice. 

Donoghue JM (1998). Selective serotonin re-uptake inhibitor use in primary care a five year naturalistic study. Clin Drug Invest 16, 453-62. 

Henderson DC, Cagliero E, Gray C, Nasrallah RA, Hayden DL, Schoen-feld DA et al. Clozapine, diabetes melli-tus, weight gain, and lipid abnormalities A five-year naturalistic study. Am J Psychiatry 2000 157(6) 975—981. 

Eor many years, lithium salts have been used for maintenance treatment. However, naturalistic studies have reported a relatively high failure rate in patients on lithium and therefore other therapeutic approaches have been considered. 

Strober, M., Morrell, W., Lampert, C., and Burroughs,/. (1990) Relapse following discontinuation of lithium maintenance therapy in adolescents with bipolar I illness a naturalistic study. Am J Psychiatry 147 457—461. 

Biederman, J., Baldessarini, R., Goldblatt, A., Lapey, K., Doyle, A., and Hesslein, P. (1993a) A naturalistic study of 24-hour electrocardiographic recordings and echocardiographic finding in children and adolescents treated with desipramine. / Am Acad Child Adolesc Psychiatry 32 805-813. 

Wood et al., 1996 Emslie et al., 1998 Birmaher et al., 2000a). Naturalistic studies of children and adolescents and controlled trials in adults show that continuation medication and/or psychotherapy can reduce relapses (Fava et al., 1996 Kroll et ah, 1996 Mufson and Fairbanks, 1996 Emslie et ah, 1998). Patients treated with psychotherapy alone or in combination with medications should continue psychotherapy biweekly to monthly, depending on the presence of factors that increase the risk of relapse. The patient and family should be taught to recognize early signs of relapse. 

Factors associated with increased risk for recurrence in naturalistic studies of depressed children and adolescents may serve as guidance to the clinician to decide who needs maintenance treatment. These factors include history of prior depressive episodes, female sex, late onset, suicidality, double depression, subsyndromal symptoms, poor functioning, personality disorders, exposure to negative events (e.g., abuse, conflicts), and family history of recurrent MDD (<2 episodes) (Birmaher et ah, 1996 a,b Goodyer et ah, 1998 Fewin-sohn et ah, 1999 Rao et ah, 1999 Rueter et al., 1999 Weissman et ah, 1999a, b Klein et ah, 2001). 

Medication resistance. Sackeim et al. (1990) conducted a prospective, naturalistic study of relapse rates in 58 patients who were followed up to 1 year after ECT. The investigators used methods similar to those of Prudic et al. (1990) the patients were rated for their degree of medication resistance during the index episode before ECT. In most cases, continuation pharmacotherapy was at the discretion of the patient s private physician. Relapse following ECT was twice as common in patients who were medication resistant before ECT than in nonresistant patients (64% versus 32%). Eurther-more, among medication-resistant patients, the adequacy of continuation pharmacotherapy had no effect on relapse rates. In a lithium continuation trial post-ECT, Shapira et al. (1995) also found that patients who were medication-resistant were more likely to relapse than were patients who were not known to be medication-resistant before ECT. 

One naturalistic study found that weight gain did not plateau with clozapine therapy until year 4, and the weight gain was not dose related (Henderson et al. 2000). Patients should receive nutritional counseling at the initiation of treatment with clozapine. 

The relocation of treatment from chronic hospital settings to outpatient community mental health centers is, in great part, due to the efficacy of antipsychotics. Naturalistic studies before the era of psychotropics revealed that two of three psychotic patients (primarily schizophrenic) spent most of their lives in state asylums. Before the mid-1950 s, there had been a steady increase in state hospital populations, which paralleled the general population growth, but after the introduction of antipsychotics, there was a marked reduction in those hospitalized for various psychoses. Presently, more than 95% of these patients live outside of the hospital, even though many continue to relapse or demonstrate residual symptoms. Thus, although the antipsychotics have not been a panacea, they make community-based care a reality for many who would otherwise have remained chronically institutionalized. 

Olanzapine Versus Risperidone. Several naturalistic studies compared olanzapine with risperidone, usually finding these drugs produced the same overall efficacy. One study conducted at Riverview Hospital in British Columbia, however, found that 60% of risperidone patients were responders, compared with only 27% of olanzapine patients, and that the speed of response to risperidone was 14 days compared with 23 days with olanzapine. The mean dose of risperidone was 4.8 mg/day and for olanzapine 14.3 mg/day (120). 

One noteworthy naturalistic study (43) compared the incidence of suicidal behavior with the prescribed dose of heterocyclic antidepressant (HCA) and found the rate was 22% for low doses (i.e., less than 75 mg per day) but decreased progressively as the HCA dose was increased (i.e., 11% at 75 to 149 mg per day 1% at 150 to 249 mg per day and 0.5% at 250fall+also mg per day). This finding is even more remarkable considering that the more severely ill patients would be receiving the higher doses. 

Clozapine Longitudinal Trials. In a naturalistic study design, Banov et al. (300) found clozapine was an effective long-term treatment in mood disorders, particularly nondepressed affective patients. After a chart review, the authors identified 193 treatment-resistant patients, including the following ... 

Black DW, Winokur G, Nasrallah H. Treatment of mania a naturalistic study of ECT versus lithium in 438 patients. J Clin Psychiatry 1987 48 132-139. 

Fenfluramine augmentation of SRIs in one open study benefited six of seven patients (233). Many patients have both Tourette s and OCD symptoms, and one case study found that pimozide helped Tourette s symptoms, whereas fluvoxamine helped the OCD symptoms, suggesting some specificity for each symptom (234). In a naturalistic study of Tourette s with associated OCD, adjunctive fluoxetine produced 81% improvement in the complicating OCD symptoms (235). 

Martinsen EW, Olsen T, Tonset E, et al. Cognitive-behavioral group therapy for panic disorder in the general clinical setting a naturalistic study with 1-year follow-up. J Clin Psychiatry 1998 59 437-442. 

There are no studies to guide how long antidepressants should be continued in children and adolescents once a response has been achieved. A naturalistic study by Emsiie and colleagues (130) of 70 children and adolescents with MDD revealed that 98% recovered from their index episodes of MDD within 1 year of their initial evaluation. More than 80% received antidepressants, but the nature of the treatment was determined by the individual clinician rather than dictated by a treatment protocol. More than 60% of these patients had at least one recurrence during a 1- to 5-year follow-up period. Of those with a recurrence, 47% occurred within 1 year of their recovery and 70% within 2 years. These results are consistent with earlier studies indicating that 54% to 72% of children and adolescents with MDD have a recurrent episode when followed up for 3 to 8 years (130, 131). Until studies are done, it would seem prudent to follow the same continuation and maintenance treatment guidelines for children and adolescents as for adults with MDD (see Chapter 7). 

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