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Meta-Analysis
. 2014 Jun 10;2014(6):CD001470.
doi: 10.1002/14651858.CD001470.pub2.

Flupenthixol decanoate (depot) for schizophrenia or other similar psychotic disorders

Jataveda Mahapatra  1 , Seema N Quraishi, Anthony David, Stephanie Sampson, Clive E Adams
Affiliations
Meta-Analysis

Flupenthixol decanoate (depot) for schizophrenia or other similar psychotic disorders

Jataveda Mahapatra et al. Cochrane Database Syst Rev. .

Abstract

Background: Long-acting depot injections of drugs such as flupenthixol decanoate are extensively used as a means of long-term maintenance treatment for schizophrenia.

Objectives: To evaluate the effects of flupenthixol decanoate in comparison with placebo, oral antipsychotics and other depot neuroleptic preparations for people with schizophrenia and other severe mental illnesses, in terms of clinical, social and economic outcomes.

Search methods: We identified relevant trials by searching the Cochrane Schizophrenia Group Trials Register in March 2009 and then for this update version, a search was run in April 2013. The register is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO. References of all identified studies were inspected for further trials. We contacted relevant pharmaceutical companies, drug approval agencies and authors of trials for additional information.

Selection criteria: All randomised controlled trials that focused on people with schizophrenia or other similar psychotic disorders where flupenthixol decanoate had been compared with placebo or other antipsychotic drugs were included. All clinically relevant outcomes were sought.

Data collection and analysis: Review authors independently selected studies, assessed trial quality and extracted data. For dichotomous data we estimated risk ratios (RR) with 95% confidence intervals (CI) using a fixed-effect model. Analysis was by intention-to-treat. We summated normal continuous data using mean difference (MD), and 95% CIs using a fixed-effect model. We presented scale data only for those tools that had attained prespecified levels of quality. Using Grading of Recommendations Assessment, Development and Evaluation (GRADE) we created 'Summary of findings tables and assessed risk of bias for included studies.

Main results: The review currently includes 15 randomised controlled trials with 626 participants. No trials compared flupenthixol decanoate with placebo.One small study compared flupenthixol decanoate with an oral antipsychotic (penfluridol). Only two outcomes were reported with this single study, and it demonstrated no clear differences between the two preparations as regards leaving the study early (n = 60, 1 RCT, RR 3.00, CI 0.33 to 27.23,very low quality evidence) and requiring anticholinergic medication (1 RCT, n = 60, RR 1.19, CI 0.77 to 1.83, very low quality evidence).Ten studies in total compared flupenthixol decanoate with other depot preparations, though not all studies reported on all outcomes of interest. There were no significant differences between depots for outcomes such as relapse at medium term (n = 221, 5 RCTs, RR 1.30, CI 0.87 to 1.93, low quality evidence), and no clinical improvement at short term (n = 36, 1 RCT, RR 0.67, CI 0.36 to 1.23, low quality evidence). There was no difference in numbers of participants leaving the study early at short/medium term (n = 161, 4 RCTs, RR 1.23, CI 0.76 to 1.99, low quality evidence) nor with numbers of people requiring anticholinergic medication at short/medium term (n = 102, 3 RCTs, RR 1.38, CI 0.75 to 2.25, low quality evidence).Three studies in total compared high doses (100 to 200 mg) of flupenthixol decanoate with the standard doses (˜40mg) per injection. Two trials found relapse at medium term (n = 18, 1 RCT, RR 1.00, CI 0.27 to 3.69, low quality evidence) to be similar between the groups. However people receiving a high dose had slightly more favourable medium term mental state results on the Brief Psychiatric Rating Scale (BPRS) (n = 18, 1 RCT, MD -10.44, CI -18.70 to -2.18, low quality evidence). There was also no significant difference in the use of anticholinergic medications to deal with side effects at short term (2 RCTs n = 47, RR 1.12, CI 0.83 to 1.52 very low quality evidence). One trial comparing a very low dose of flupenthixol decanoate (˜6 mg) with a low dose (˜9 mg) per injection reported no difference in relapse rates (n = 59, 1 RCT, RR 0.34, CI 0.10 to 1.15, low quality evidence).

Authors' conclusions: In the current state of evidence, there is nothing to choose between flupenthixol decanoate and other depot antipsychotics. From the data reported in clinical trials, it would be understandable to offer standard dose rather than the high dose depot flupenthixol as there is no difference in relapse. However, data reported are of low or very low quality and this review highlights the need for large, well-designed and reported randomised clinical trials to address the effects of flupenthixol decanoate.

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Conflict of interest statement

None known.

Figures

1
1
Study flow diagram: review update for 2009 and 2013
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 FLUPENTHIXOL DECANOATE vs ORAL ANTIPSYCHOTICS, outcome: 1.1 Leaving the study early.
1.1
1.1. Analysis
Comparison 1 FLUPENTHIXOL DECANOATE vs ORAL ANTIPSYCHOTICS, Outcome 1 Leaving the study early.
1.2
1.2. Analysis
Comparison 1 FLUPENTHIXOL DECANOATE vs ORAL ANTIPSYCHOTICS, Outcome 2 Adverse effects: 1. general ‐ movement disorders.
2.1
2.1. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 1 Clinical response: 1. mental state ‐ relapse.
2.4
2.4. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 4 Clinical response: 4. global state ‐ 'not minimally better' (five point scale).
2.5
2.5. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 5 Clinical response: 5. global state ‐ 'not clearly better' (five point scale).
2.6
2.6. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 6 Clinical response: 6. global state ‐ no clinical improvement.
2.7
2.7. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 7 Leaving the study early.
2.8
2.8. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 8 Adverse effects: 1. general ‐ non‐specific.
2.9
2.9. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 9 Adverse effects: 2. general ‐ movement disorders.
2.10
2.10. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 10 Adverse effects: 3. specific ‐ movement disorders.
2.11
2.11. Analysis
Comparison 2 FLUPENTHIXOL DECANOATE vs OTHER DEPOT ANTIPSYCHOTICS, Outcome 11 Adverse effects: 4. specific ‐ anticholinergic effects.
3.1
3.1. Analysis
Comparison 3 FLUPENTHIXOL DECANOATE HIGH DOSE vs FLUPENTHIXOL DECANOATE STANDARD DOSE (˜40 mg/IM), Outcome 1 Clinical response: 1. mental state ‐ relapse.
3.2
3.2. Analysis
Comparison 3 FLUPENTHIXOL DECANOATE HIGH DOSE vs FLUPENTHIXOL DECANOATE STANDARD DOSE (˜40 mg/IM), Outcome 2 Clinical response: 2. mental state ‐ general score (BPRS endpoint scores, high score = poor).
3.3
3.3. Analysis
Comparison 3 FLUPENTHIXOL DECANOATE HIGH DOSE vs FLUPENTHIXOL DECANOATE STANDARD DOSE (˜40 mg/IM), Outcome 3 Leaving the study early.
3.4
3.4. Analysis
Comparison 3 FLUPENTHIXOL DECANOATE HIGH DOSE vs FLUPENTHIXOL DECANOATE STANDARD DOSE (˜40 mg/IM), Outcome 4 Adverse effects: 1. general ‐ movement disorders.
4.1
4.1. Analysis
Comparison 4 FLUPENTHIXOL DECANOATE VERY LOW (˜6 mg/IM) DOSE vs FLUPENTHIXOL DECANOATE LOW DOSE (˜9 mg/IM), Outcome 1 Clinical response: 1. mental state ‐ relapse.
See this image and copyright information in PMC

Update of

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    1. Hertling I, Dvorak A, Glaser T, Philipp M, Beneke M, Ramskogler K, et al. Influence of psychopathological symptoms on subjective quality of life of schizophrenic patients [Der einfluss psychopathologischer symptome auf die subjektive lebensqualitiat schizophrener patienten]. Psychopharmakotherapie 2003;10(4):151‐8. [EMBASE: 2003494380]
Hillert 1994 {published data only}
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Hirsch 1986 {published data only}
    1. Hirsch SR, Jolley AG, Manchanda R, McRink A. Intermittent medication as an alternative to maintenance medication in the treatment of schizophrenia: a preliminary report [Fruehzeitige medikamentoese Intervention als Alternative zur Depot‐Dauer‐Medikation in der Schizophreniebehandlung Ein vorlaeufiger Bericht]. In: Boeker W, Brenner HD editor(s). Bewaltigung der Schizophrenie. Bern, Switzerland: Verlag Hans Huber, 1986:62‐71. [PSYNDEX: 20591]
Huang 1995 {published data only}
    1. Huang J, Shuai Y, Cai C. A study on therapeutic efficacy of flupenthixol in treating chronic schizophrenics of type II. Chinese Journal of Neurology and Psychiatry 1995;28(5):269‐72. [EMBASE: 1996089743; CAJ]
Ishimaru 1971 {published data only}
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Johnson 1975 {published data only}
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Jorgensen 1980 {published data only}
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Jorgensen 1982 {published data only}
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Joseph 1979 {published data only}
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Ju 1996 {published data only}
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Kelemen 2006a {published data only}
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King 2002 {published data only}
    1. King KG, Dittmann RW, Diehl A, Hubrich P, Maras A, Gattaz WF. Randomized double‐blind trial: olanzapine vs flupenthixol. 12th World Congress of Psychiatry; 2002 Aug 24‐29; Yokohama, Japan. 2002. [EMBASE: 2002386502]
Kistrup 1991 {published data only}
    1. Kistrup K, Gerlacj J, Aaes‐Jorgensen T, Larsen N. Perphenazine decanoate and cis(z)‐flupenthixol decanoate in maintenance treatment of schizophrenic outpatients. Psychopharmacology 1991;105:42‐8. - PubMed
Knights 1979 {published data only}
    1. Knights A, Okasha MS, Salih MA, Hirsch SR. Depressive and extrapyramidal symptoms and clinical effects: a trial of fluphenazine versus flupenthixol in maintenance of schizophrenic out‐patients. British Journal of Psychiatry 1979;135:515‐23. - PubMed
Kong 1989 {published data only}
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Lapierre 1983 {published data only}
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Leff 1971 {published data only}
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Liu 1999a {published data only}
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Liu 2000a {published data only}
    1. Liu QZ, Wang LH, Han YF, Zhou CL, Wang LH. A comparative study of fluanxol and chlorpromazine used for schizophrenia. Journal of Taishan Medical College 2000;21(2):117‐21.
Macmillan 1984 {published data only}
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MacMillan 1986 {published data only}
    1. MacMillan JF, Crow TJ, Johnson AL, Johnstone EC. Short‐term outcome in trial entrants and trial eligible patients. British Journal of Psychiatry 1986;148(2):128‐33. [EMBASE: 1986102574; MEDLINE: ; MEDLINE: ; PASCAL] - PubMed
McCreadie 1989 {published data only}
    1. McCreadie RG, Wiles D, Grant S, Crockett GT, Mahmood Z, Livingston MG, et al. The Scottish first episode schizophrenia study. VII. Two‐year follow‐up. Scottish Schizophrenia Research Group. Acta Psychiatrica Scandinavica 1989;80(6):597‐602. [MEDLINE: ] - PubMed
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Mueller 1997 {published data only}
    1. Mueller MJ BO. Depressive symptoms in acute schizophrenia: evaluation and outcome under new antipsychotics. European Neuropsychopharmacology 1997;7(Suppl 2):S227‐8.
Mueller 2002 {published data only}
    1. Mueller MJ, Wetzel H, Benkert O. Differential effects of high‐dose amisulpride versus flupentixol on latent dimensions of depressive and negative symptomatology in acute schizophrenia: An evaluation using confirmatory factor analysis. International Clinical Psychopharmacology 2002;17(5):249‐61. [BIOSIS: 550227] - PubMed
Muller 1997 {published data only}
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Muller 1998 {published data only}
    1. Muller MJ, Wetzel H, Benkert O. Differential treatment effects of amisulpride versus flupentixol on latent dimensions of depressive and negative symptoms in acute schizophrenia. Schizophrenia Research 1998;29(1,2):157. [MEDLINE: ; MEDLINE: ] - PubMed
Müller 1998a {published data only}
    1. Müller MJ, Wetzel H, Benkert O. Depressive symptoms in acute psychotic disorders: evaluation methods and treatment strategies. 21st Collegium Internationale Neuro‐Psychopharmacologicum Congress; 1998 Jul 12‐16; Glasgow, UK. 1998. [MEDLINE: ; MEDLINE: ]
    1. Müller MJ, Wetzel H, Benkert O. Latent dimensions of depressive and negative symptoms in acute schizophrenia: treatment effects of high dose amisulpride vs. flupentixol. 11th European College of Neuropsychopharmacology Congress; 1998 Oct 31 ‐ Nov 4; Paris, France. 1998. [11TH: Congress of the European College of Neuropsychopharmacology [CD‐ROM]: Conifer, Excerpta Medica Medical Communications BV, 1998]
Owen 1981 {published data only}
    1. Owen F, Bourne RC, Crow TJ, Fadhli AA, Johnstone EC. Platelet monoamine oxidase activity in acute schizophrenia: relationship to symptomatology and neuroleptic medication. British Journal of Psychiatry 1981;139:16‐22. [MEDLINE: ; MEDLINE: ] - PubMed
O’Regan 2005 {published data only}
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Pach 1998 {published data only}
    1. Pach J, Finkbeiner T, Wolstein J, Glaser T. Maintenance therapy with flupenthixol‐decanoate in chronic schizophrenics: a one‐year follow‐up study. XXIst C.I.N.P. Congress. Glasgow, Scotland, UK. July 12‐16, 1998. Awaiting translation.
Parent 1982 {published data only}
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Philipp 2003 {published data only}
    1. Philipp M, Lesch OM, Schmauss M, Dose M, Glaser T. Comparative effectiveness of flupenthixol and risperidone on negative symptoms [Vergleichbare Wirksamkeit von Flupentixol und Risperidon auf schizophrene Negativsymptomatik]. Psychiatrische Praxis 2003;30(Suppl 2):S94‐6. [MEDLINE: ] - PubMed
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Rein 1996 {published data only}
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Ropert 1973 {published data only}
    1. Ropert R, Levy L, Ropert M. Problems posed by trial use of prolonged action neuroleptics in acute psychiatric syndromes [Problemes poses par les essais d'emploi des neuroleptiques a action prolongee (N A P ) dans les syndromes psychiatriques aigus]. Annales Medico‐Psychologiques 1973;1(2):259‐67. [PsycINFO] - PubMed
Ruhrmann 2007 {published data only}
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Schlosser 2002 {published data only}
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Simon 1978 {published data only}
    1. Simon P, Fermanian J, Ginestet D, Goujet MA, Peron Magnan P. Standard and long‐acting depot neuroleptics in chronic schizophrenics: an 18‐month open multicentric study. Archives of General Psychiatry 1978;35(7):893‐7. [MEDLINE: ; MEDLINE: ] - PubMed
Singh 1984 {published data only}
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Stauning 1979 {published data only}
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Steuber 1978 {published data only}
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Strous 2007 {published data only}
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Trueman 1974 {published data only}
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Tuninger 1994 {published data only}
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Tuninger 1996 {published data only}
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Turbott 1985 {published data only}
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Turbott 1987 {published data only}
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Vaddadi 1986a {published data only}
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Vinar 1976 {published data only}
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Wetzel 1995 {published data only}
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Wetzel 1998 {published data only}
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Wistedt 1981 {published data only}
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Wistedt 1995 {published data only}
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Yin 2005 {published data only}
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Youssef 1991a {published data only}
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