Here is an example of what a study-based record looks like. Thanks to the Cochrane Schizophrenia Group for allowing us to use this record from their MeerKat register.
|
Study name |
Beasley 1996 |
|
Study design |
RCT |
|
Blinding |
Double-blind |
|
Absolute number
of participants |
152 |
|
Country of origin |
USA |
|
Health condition |
Acute Exacerbation |
|
Age |
Adults |
|
Interventions |
Dosage of Drug |
|
Outcomes |
Abnormal Involuntary Movement Scale (AIMS) |
|
Link to Cochrane
review |
|
|
Collaborative
Review Group |
Cochrane Schizophrenia Group |
·
[1996]
Olanzapine versus placebo, results of the United-States double-blind olanzapine
trial
·
[1995]
Additional clinical experience with olanzapine, an atypical antipsychotic
·
[1996]
Olanzapine versus placebo - results of a double-blind, fixed dose olanzapine
trial
|
Title |
The acute and long-term effect of olanzapine compared with
placebo and haloperidol on serum prolactin concentration |
|
Authors |
B. JONES et al. |
|
Source |
Schizophrenia Research |
|
Date of publication |
1998 |
|
Volume |
29 |
|
Issue |
1,2 |
|
Pages |
204 |
|
Abstract |
Prolaction elevation is both a common and persistent event
with the currently marketed antipsychotic, excluding clozapine. Elevations
have been associated with both acute (galactorrhea, amenorrhea) and chronic
(predisposition to osteoporosis) treatment-emergent adverse events. One of
the defining criteria for an atypical antipsychoitc is the relative lack of
persistent prolactinemia. |
|
Language |
English |
|
Title |
What is the differential risk of tardive dyskinesia with the
atypical antipsychotic olanzapine? |
|
Authors |
R. N. TAMURA et al. |
|
Source |
Schizophrenia Research |
|
Date of publication |
1998 |
|
Volume |
29 |
|
Issue |
1 |
|
Pages |
176 |
|
Abstract |
The incidene of tardive dyskinesia (TD) was evaluated in 1714
patients with schizophrenia, schizophreniform disorder, or schizoaffective
disorder treated with olanzapine or haloperidol for a period of up to 2.6
years in three randomized, double-blin, multicentre studies. It was
hypothesized that olanzapine would be associated with a lower incidence of TD
than haloperidol. |
|
Language |
English |
|
Title |
Extrapyramidal symptoms and tolerability of olanzapine versus
haloperidol in the acute treatment of schizophrenia |
|
Authors |
P. V. TRAN et al. |
|
Source |
Journal of Clinical Psychiatry |
|
Date of publication |
1997 |
|
Volume |
58 |
|
Issue |
5 |
|
Pages |
205-11 |
|
Abstract |
BACKGROUND: A relative lack of extrapyramidal symptoms (EPS,
i.e., the syndromes of dystonia, parkinsonism, akathisia, dyskinesia) is one
criterion used to determine whether an antipsychotic is atypical. The
extrapyramidal symptom profiles of the novel antipsychotic olanzapine and the
conventional antipsychotic haloperidol were compared in a population of 2606
patients from three well-controlled prospective clinical trials. METHOD:
Extrapyramidal symptom data were analyzed for 1796 patients treated with
olanzapine (5 to 20 mg/day) and 810 patients treated with haloperidol (5 to
20 mg/day) for up to 6 weeks of therapy. Patients were monitored weekly by
three methods of extrapyramidal symptom assessment: (1) detection of
extrapyramidal adverse events (signs and symptoms) by casual observation,
nonprobing inquiry, and spontaneous report; (2) objective rating scale
scores: and (3) use of concomitant anticholinergic medications. Emergence of
EPS was assessed by (1) analysis of the incidence of extrapyramidal syndrome
categories based on adverse events, (2) the incidence of extrapyramidal
syndromes based on categorical analysis of rating scale scores, (3) analysis
of mean maximum change in rating scale scores, and (4) categorical analysis
of anticholinergic medication use. Outcome of EPS was assessed by (1)
analysis of mean change in rating scale scores at endpoint and (2) mean
anticholinergic use at endpoint. RESULTS: Olanzapine was statistically
significantly (p = .014, p < .001) superior to haloperidol in all four
analyses related to emergence of EPS and in the two analyses related to
outcome. Furthermore, during acute treatment, statistically significantly
fewer patients treated with olanzapine (0.3%) discontinued the study because
of any extrapyramidal adverse event than patients treated with haloperidol
(2.7%, p < .001). CONCLUSION: Olanzapine exhibited a statistically
significantly lower extrapyramidal symptom profile than the conventional
antipsychotic haloperidol at comparably effective antipsychotic doses. The
lower extrapyramidal symptom profile with olanzapine was evident despite
statistically significantly more frequent use of anticholinergic drugs among
haloperidol-treated patients. Fewer olanzapine-treated than
haloperidol-treated patients discontinued because of EPS, suggesting that
olanzapine should contribute to better compliance with longer term
maintenance treatment, with minimal anticholinergic-associated events. |
|
Language |
English |
|
MEDLINE Accession Number |
97328056 |
|
Available Links |
Link to the PubMed abstract on the National Library of
Medicine website |
|
Keywords |
Adult-; Antipsychotic-Agents-Adverse-Effects;
Basal-Ganglia-Diseases-Epidemiology; Double-Blind-Method;
Drug-Administration-Schedule; Drug-Tolerance; Haloperidol-Adverse-Effects;
Incidence-; Patient-Compliance; Patient-Dropouts;
Pirenzepine-Adverse-Effects; Pirenzepine-Therapeutic-Use; Treatment-Outcome.
*Antipsychotic-Agents-Therapeutic-Use;
*Basal-Ganglia-Diseases-Chemically-Induced; *Haloperidol-Therapeutic-Use;
*Pirenzepine-Analogs-and-Derivatives; *Schizophrenia-Drug-Therapy; ; Adult;
Antipsychotic Agents/ae [Adverse Effects]; *Antipsychotic Agents/tu
[Therapeutic Use]; *Basal Ganglia Diseases/ci [Chemically Induced]; Basal
Ganglia Diseases/ep [Epidemiology]; Comparative Study; Double-Blind Method;
Drug Administration Schedule; Drug To |
|
Title |
Olanzapine versus placebo, results of the United-States
double-blind olanzapine trial |
|
Authors |
C. BEASLEY et al. |
|
Source |
20th Congress of the Collegium Internationale
Neuro-psychopharmacologicum; 1996 Jun 23-27; Melbourne, Australia |
|
Date of publication |
1996 |
|
Abstract |
Study HGAP (n = 152) was a multicenter, double-blind,
parallel trial comparing 2 fixed doses of olanzapine (Olz10.0, 10 mg/day and
Olz1.0, 1 mg/day) to placebo with schizophrenic patients. The patients had an
initial BPRS Total score of at least 24 (items scored 0). Efficacy analyses
indicated that the Olz10.0 treatment group experienced statistically
significantly greater mean improvement in BPRS Total, BPRS Positive, PANSS
Total, PANSS Positive, PANSS Negative and PANSS General Psychopathology
scores than the placebo treatment group. No statiscally significant
differences were found between Olz1.0 and placebo in any of the efficacy
scales. There were no adverse events reported at a statistically
significantly greater rate among Olz10.0 treated patients compared to placebo
treated patients. Very few treatment emergent events resulted in patient
discontinuation from the olanzapine treatment arms (9.6% Olz1.0; 4% Olz10.0).
A negligible number of treatment emergent extrapyramidal symptoms occured in
patients on olanzapine. The results of this study indicates that olanzapine
was effective in treating both the positive and negative symptoms of
schizophrenia and was well tolerated. |
|
Language |
English |
|
Title |
The acute and long-term effect of olanzapine compared with
placebo and haloperidol on serum prolactin concentrations |
|
Authors |
A. M. CRAWFORD et al. |
|
Source |
Schizophrenia Research |
|
Date of publication |
1997 |
|
Volume |
26 |
|
Issue |
1 |
|
Pages |
41-54 |
|
Abstract |
Prolactin elevation is both a common and a persistent event
with the currently marketed antipsychotics, excluding clozapine. Elevations
have been associated with both acute (galactorrhea, amenorrhea) and chronic
(predisposition to osteoporosis) treatment-emergent adverse events. One of
the defining criteria for an atypical antipsychotic is the relative lack of
persistent prolactinemia. A double-blind, placebo- (N = 68) and haloperidol-
(Hal: 15 +/- 5 mg/day, N = 69) controlled trial of three dose ranges of
olanzapine (Olz-L: 5 +/- 2.5 mg/day, N = 65; Olz-M: 10 +/- 2.5 mg/day, N =
64; Olz-H: 15 +/- 2.5 mg/day, N = 69) in the treatment of schizophrenia
afforded the opportunity to assess the temporal course of the influence of
olanzapine and haloperidol on serum prolactin concentration. Consistent with
its potent D2 antagonism, haloperidol was associated with a statistically
significantly higher incidence of treatment-emergent prolactin elevation
(72%) than seen with placebo (8%; p < 0.001) at week 2 of therapy.
Expectedly, this elevation was also persistent at weeks 4 and 6. In contrast,
olanzapine-associated treatment- emergent prolactin elevations were both
lower in magnitude and transient. At week 2, 38% of the Olz-H, 24% of the
Olz-M, and 13% of the Olz- L treatment groups exhibited a treatment-emergent
prolactin elevation, with a mean increase of 0.35, 0.52, and 0.61 nmol/l,
respectively; for haloperidol the mean increase was 1.23 nmol/l. For only the
Olz-M and the Olz-H treatment groups did the week 2 incidence of treatment-
emergent prolactin elevations differ statistically significantly from
placebo. Both the incidence of elevations and the mean increase, in prolactin
concentration were less than that seen with haloperidol. Furthermore, by
treatment week 6, all three olanzapine groups exhibited incidences of
treatment-emergent prolactin elevation that were comparable to placebo and
were statistically significantly less than observed with haloperidol. Rapid
adaptation was observed in the temporal course of prolactin elevations
associated with olanzapine based on both the categorical analysis of
treatment-emergent high values and the analyses of temporal change in mean
concentrations. In contrast to haloperidol, the magnitudes of the treatment-emergent
elevations associated with olanzapine were minimal. The rates of elevation
were approximately one-half to one-third those observed with haloperidol and
were significantly more transient. Olanzapine, even at the highest doses (15
+/- 2.5 mg/day) used, was not associated with persistent elevations of
prolactin, consistent with an 'atypical' pharmacologic profile. |
|
Language |
English |
|
MEDLINE Accession Number |
98017425 |
|
Available Links |
Link to the PubMed abstract on the National Library of
Medicine website |
|
Keywords |
; Adult; *Antipsychotic Agents/ae [Adverse Effects];
Antipsychotic Agents, Butyrophenone/ae [Adverse Effects]; Chi-Square
Distribution; Cross-Sectional Studies; Dopamine Antagonists/ae [Adverse
Effects]; Double-Blind Method; Female; *Haloperidol/ae [Adverse Effect;
Adult-; Antipsychotic-Agents,-Butyrophenone-Adverse-Effects;
Chi-Square-Distribution; Cross-Sectional-Studies; Dopamine- |
|
Title |
Randomised double-blind comparison of the incidence of
tardive dyskinesia in patients with schizophrenia during long-term treatment
with olanzapine or haloperidol |
|
Authors |
C. M. BEASLEY et al. |
|
Source |
British Journal of Psychiatry |
|
Date of publication |
1999 |
|
Volume |
174 |
|
Pages |
23-30 |
|
Abstract |
BACKGROUND: Tardive dyskinesia is important in the
side-effect profile of antipsychotic medication. AIMS: The development of
tardive dyskinesia was evaluated in patients treated with double-blind,
randomly assigned olanzapine or haloperidol for up to 2.6 years. METHODS:
Tardive dyskinesia was assessed by the Abnormal Involuntary Movement Scale
(AIMS) and Research Diagnostic Criteria for Tardive Dyskinesia (RD-TD), it
was defined as meeting RD-TD criteria at two consecutive assessments. The
risk of tardive dyskinesia, the relative risk, incidence rate, and incidence
rate ratio were estimated. RESULTS: The relative risk of tardive dyskinesia
for the overall follow up period for haloperidol (n = 522) v. olanzapine (n =
1192) was 2.66 (95% CI = 1.50-4.70). Based on data following the initial six
weeks of observation (during which patients underwent medication change and
AIMS assessments as frequently as every three days), the one-year risk was
0.52% with olanzapine (n = 513) and 7.45% with haloperidol (n = 114). The
relative risk throughout this follow-up period was 11.37 (95% CI =
2.21-58.60). CONCLUSION: Our results indicated a significantly lower risk of
tardive dyskinesia with olanzapine than with haloperidol. |
|
Language |
English |
|
MEDLINE Accession Number |
99227593 |
|
Available Links |
Link to the PubMed abstract on the National Library of
Medicine website |
|
Keywords |
; *Antipsychotic Agents/ae [Adverse Effects]; Double-Blind
Method; *Dyskinesia, Drug-Induced/et [Etiology]; *Haloperidol/ae [Adverse
Effects]; Human; Pirenzepine/ae [Adverse Effects]; *Pirenzepine/aa [Analogs
& Derivatives]; Risk Factors; *Schizophrenia/dt [Drug T;
Double-Blind-Method; Pirenzepine-Adverse-Effects; Risk-Factors;
Survival-Analysis. *Antipsychotic-Agents-Adverse-Effects;
*Dyskinesia,-Drug-Induced-Etiology; *Haloperidol-Adverse-Effects;
*Pirenzepine-Analogs-And-Derivatives; *Schizophrenia-Drug-Therapy.
Antipsychotic-Agents; olanzapine; Pirenzepine; Haloperidol |
|
Title |
Additional clinical experience with olanzapine, an atypical
antipsychotic |
|
Authors |
W. SATTERLEE et al. |
|
Source |
Schizophrenia Research |
|
Date of publication |
1995 |
|
Volume |
15 |
|
Issue |
1,2 |
|
Pages |
163 |
|
Abstract |
Olanzapine, structurally a thienobenzodiazepine, has
demonstrated in vitro affinity for serotonin (5-HT)2a, 5-HT2c, dopamine (D)2,
D4, D1, muscarine (particularly M1), x1-adrenergic, and H1 receptors. This
broad receptor profile includes greater activity at 5-HT2a than at D2
receptors. In a randomized DOUBLE blind mulicentre clinical trial desinged to
test the efficacy and safety of olanzapine, 152 schizophrenic patients were
randomly assinged to 1 or 10 mg/d of olanzapine or placebo (Pbo). When
baseline and endpoint scores were compared, the 10 mg dose olanzapine (-7.7)
was statistically significantly superior to bo (-0.4) relative to mean change
in BPRS positive, PANSS total, PANSS positive, and PANSS negative scores were
compared olanzapine (10 mg) was statistically significally superior to Pbo
and few treatment emergent extrapyramidal symptoms occurred in patients on
olanzapine. Olanzapine (1mg does) was not significantly different than Pbo in
terms of efficacy. Olanzapine's receptor profile, efficacy and its safety
profile strongly suggest that olanzapine is a very promising atypical
antipsychotic agent. |
|
Language |
English |
|
Title |
Olanzapine versus placebo - results of a double-blind, fixed
dose olanzapine trial |
|
Authors |
J. r. BEASLEY CM et al. |
|
Source |
Psychopharmacology |
|
Date of publication |
1996 |
|
Volume |
124 |
|
Issue |
1-2 |
|
Pages |
159-67 |
|
Abstract |
Olanzapine is a potential new 'atypical' anTI:psychotic
agent. This double-blind, acute phase study compared two doses of olanzapine
[1 mg/day (Olz1.0); 10 mg/day (Olz10.0)] with placebo in the treatment of 152
patients who met the DSM-III-R criteria for SCHIZophrenia and had a Brief
Psychiatric Rating Scale (BPRS)-total score (items scored 0-6)>=24. In
overall symptomatology improvement [BPRS-total score and Positive and
Negative Syndrome Scale (PANSS)-total score], Olz10.0 was statistically
significantly superior to placebo. In positive symptom improvement
(PANSS-positive score, BPRS-positive score), Olz10.0 was statistically
significantly superior to placebo. In negative symptom improvement
(PANSS-negative score), Olz10.0 was statistically superior to placebo. Olz
1.0 was clinically comparable to placebo in all efficacy comparisons. The
only adverse event to show an overall statistically significant incidence
difference was anorexia (reported for 10% of placebo- treated and 0% of
Olz10.0- treated patients). The Olz10.0-treated patients improved over
baseline with respect to parkinsonian and akathisia symptoms, and these
changes were comparable with those observed with placebo. There were no
dystonias associated with Olz10.0 treatment. At endpoint, the incidence of
patients with elevated prolactin values did not differ statistically
significantly between placebo-treated and Olz10.0- treated patients.
Olanzapine appears to be not only safe and effective, but a promising
atypical antipsychotic candidate. |
|
Language |
English |
|
Keywords |
neuroleptic agent/adverse drug reaction, olanzapine/adverse
drug reaction, neuroleptic agent/clinical trial, olanzapine/clinical trial, |