Page last updated: 2024-11-04

fluphenazine depot

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

fluphenazine decanoate : The prodrug of fluphenazine, an antipsychotic drug used for the symptomatic management of psychosis in patients with schizophrenia. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID3388
CHEMBL ID1200854
CHEBI ID5124
SCHEMBL ID41288
MeSH IDM0058428

Synonyms (82)

Synonym
decanoic acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester
lyogen
nsc-169510
flufenazine decanoate
decanoic acid, 2-[4-[3-[2-(trifluoromethyl)-10h-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester
fluorophenazine decanoate
moditen-depo
wln: t c666 bn isj exfff b3- at6n dntj d2ov9
dapotum d
nsc169510
sq 10,733
modecate
2-(4-{3-[2-(trifluoromethyl)-10h-phenothiazin-10-yl]propyl}piperazin-1-yl)ethyl decanoate
einecs 225-672-4
2-(4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl decanoate
nsc 169510
moditen depot
brn 0599852
decanoic acid, 2-(4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl ester
fluphenaline decanoate
decanoic acid, 2-(4-(3-(2-(trifluoromethyl)-10h-phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl ester
ccris 3954
fluphenazine o-decanoate
fluphenazine depot
5002-47-1
fluphenazine decanoate
C07956
prolixin decanoate
fluphenazine decanoate (jan/usp)
prolixin decanoate (tn)
D00793
qd-10733
sq-10733
fluphenazini decanoas
CHEMBL1200854
2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl decanoate
AKOS003589045
ftorphenazine decanoate
2-(4-(3-(2-(trifluoromethyl)-10h-phenothiazin-10-yl)propyl)piperazin-1-yl)ethyl decanoate
A827938
unii-fmu62k1l3c
fmu62k1l3c ,
fluphenazine decanoate [usp:ban:jan]
2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl decanoate
fluphenazine decanoate [usp monograph]
fluphenazine decanoate [ep monograph]
fluphenazine decanoate [jan]
decanoic acid, 2-(4-(3-(2-(trifluoromethyl)-10h-decanoate phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl ester
fluphenazine decanoate [vandf]
depot
fluphenazine decanoate [mart.]
fluphenazini decanoas [who-ip latin]
fluphenazine decanoate [usp impurity]
fluphenazine decanoate [mi]
fluphenazine enanthate impurity c [ep impurity]
fluphenazine decanoate [who-dd]
fluphenazine decanoate [orange book]
fluphenazine decanoate [who-ip]
MLS006010097
smr004701239
SCHEMBL41288
fluphenazinedecanoate
dapotum depot
CHEBI:5124 ,
anatensol decanoate
DTXSID7023069 ,
BCP18078
CS-0013962
HY-B1904
mfcd00798504
AS-11646
fluphenazine-decanoate
NCGC00386699-01
Q27278080
viqcgtzfeydqmr-uhfffaoysa-n
decanoic acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester (7ci,8ci)
fluphenazine decanoate (usp impurity)
fluphenazine decanoate (mart.)
fluphenazine decanoate (usp:ban:jan)
fluphenazine decanoate (ep monograph)
dtxcid703069
fluphenazine decanoate (usp monograph)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"The risk of adverse side effects of neuroleptic agents must be considered carefully in the treatment of acute and long-term psychotic states."( Antipsychotic drug side effects: their relationship to dose.
Kane, JM, 1985
)
0.27
" Adverse events related to movement disorders were reported in 3%."( Long-acting injectable risperidone: safety and efficacy in stable patients switched from conventional depot antipsychotics.
Eerdekens, E; Eerdekens, M; Jacko, M; Turner, M, 2004
)
0.32
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32

Pharmacokinetics

ExcerptReferenceRelevance
"This study uses the highly sensitive method of gas chromatography/mass spectrometry to compare the basic steady-state pharmacokinetic parameters of two fluphenazine decanoate formulations."( The determination of the steady-state pharmacokinetic profile of fluphenazine decanoate by gas chromatography/mass spectrometry detection.
Brown, WA; Friedhoff, LT; Glazer, WM; Marder, SR, 1992
)
0.28
" This means that it has a long half-life measurable in months rather than weeks."( Single-dose pharmacokinetics of fluphenazine after fluphenazine decanoate administration.
Cooper, TB; Levinson, DF; Lo, ES; Simpson, GM; Stephanos, MJ; Yadalam, KG, 1990
)
0.28
" Results suggested an absorption half-life of 4 weeks, although, in three cases steady state was only achieved after 11 monthly injections."( Pharmacokinetics of haloperidol and fluphenazine decanoates in chronic schizophrenia.
McCreadie, RG; Whitehead, A; Wiles, DH, 1990
)
0.28
" The enanthate produces peak plasma concentrations on days 2 to 3 and declines with an apparent elimination half-life (i."( Clinical pharmacokinetics of the depot antipsychotics.
Ereshefsky, L; Jann, MW; Saklad, SR,
)
0.13
"Precise pharmacokinetic data of long-acting neuroleptics: apparent half life (T 1/2), time of peak plasma concentration (Tmax), bioavailability, has been a major contribution to determine optimal dosage of the drug."( [Clinical pharmacokinetics of haloperidol decanoate. Comparison with other prolonged-action neuroleptics].
Levron, JC; Ropert, R,
)
0.13
"The future of depot neuroleptic therapy is discussed in terms of pharmacokinetic and pharmacodynamic research opportunities."( Future of depot neuroleptic therapy: pharmacokinetic and pharmacodynamic approaches.
Davis, CM; Ereshefsky, L; Jann, MW; Richards, A; Saklad, SR; Seidel, DR, 1984
)
0.27

Compound-Compound Interactions

ExcerptReferenceRelevance
"The results of treating 251 therapeutically resistant patients with paranoid schizophrenia by moditen-depo, its combination with other psychotic drugs or leponex was compared."( [Treatment of therapeutically resistant paranoid schizophrenic patients with Moditen-depot combined with other psychotropic drugs and Leponex].
Aranovich, AG; Gamburg, AL; Kotel'kevich, IuN; Omorokov, BM; Rasniuk, VA, 1980
)
0.26

Bioavailability

ExcerptReferenceRelevance
" The absorption rate constant is slower than the elimination rate constant and therefore, the depot antipsychotics exhibit 'flip-flop' kinetics where the time to steady-state is a function of the absorption rate, and the concentration at steady-state is a function of the elimination rate."( Clinical pharmacokinetics of the depot antipsychotics.
Ereshefsky, L; Jann, MW; Saklad, SR,
)
0.13
" Optimal dose has been determined from the bioavailability of the oral formulation and the interval between two injections, it averages 15, 20 times the oral daily dose for haloperidol decanoate."( [Clinical pharmacokinetics of haloperidol decanoate. Comparison with other prolonged-action neuroleptics].
Levron, JC; Ropert, R,
)
0.13

Dosage Studied

ExcerptRelevanceReference
" The dosage equivalency of haloperidol decanoate (1."( A randomized clinical trial of haloperidol decanoate and fluphenazine decanoate in the outpatient treatment of schizophrenia.
Annable, L; Campbell, W; Chouinard, G, 1989
)
0.28
" Consequences should be assessed by analysis of dose-response relationships, risk factors, and central nervous system (especially extrapyramidal) side effects, as well as the influence of neuroleptics on neurotransmitter systems."( Antipsychotic drug side effects: their relationship to dose.
Kane, JM, 1985
)
0.27
" It is suggested that additional studies, carefully designed, on dosage and plasma levels could help in achieving the lowest possible therapeutic dosage and thus in minimizing side effects."( Blood levels of neuroleptics: state of the art.
Simpson, GM; Yadalam, K, 1985
)
0.27
"Precise pharmacokinetic data of long-acting neuroleptics: apparent half life (T 1/2), time of peak plasma concentration (Tmax), bioavailability, has been a major contribution to determine optimal dosage of the drug."( [Clinical pharmacokinetics of haloperidol decanoate. Comparison with other prolonged-action neuroleptics].
Levron, JC; Ropert, R,
)
0.13
"Seventeen outpatients were treated with depot neuroleptics, zuclopenthixol decanoate in Viscoleo or fluphenazine decanoate in sesame oil, with dosage intervals of 3 weeks."( Comparative study of the pharmacokinetics of zuclopenthixol decanoate and fluphenazine decanoate.
Ba, B; Durand, A; Gouezo, F; Hou, N; Jørgensen, A; Viala, A, 1988
)
0.27
" There were statistically significant tendencies for mean plasma fluphenazine levels to rise and mean plasma sulfoxide levels to fall over the 6-month period of study among patients on the high dose, consistent with our previously reported observation that it takes 3-6 months to establish a steady state of fluphenazine with this dosage regimen."( The sulfoxidation of fluphenazine in schizophrenic patients maintained on fluphenazine decanoate.
Hawes, EM; Hubbard, JW; Marder, SR; May, PR; McKay, G; Midha, KK; Van Putten, T, 1987
)
0.27
" There was no significant difference in survival when the clinician was permitted to make a dosage adjustment up to 10 mg in the low-dose group and 50 mg in the higher-dose group when the patient demonstrated evidence of a symptomatic exacerbation."( Low- and conventional-dose maintenance therapy with fluphenazine decanoate. Two-year outcome.
Lebell, M; Marder, SR; May, PR; McKenzie, J; Mintz, J; Van Putten, T, 1987
)
0.27
" The mean dosage of the drug was 25-50 mg per 3-4 weeks."( [Long-term moditen-depot treatment of schizophrenic patients at a psychoneurology dispensary].
Abramova, LI; Gushanskiĭ, EL, 1986
)
0.27
" Based on the study of plasma levels achieved with FPZ-D injection and oral FPZ-H (fluphenazine HC1) in 6 patients, the dosage requirement of FPZ-D appeared to be difficult to predict from the oral dosage of FPZ-H in the same patient."( Plasma levels of fluphenazine during fluphenazine decanoate treatment in schizophrenia.
Casper, RC; Chang, SS; Davis, JM; Dysken, MW; Janicak, PG; Javaid, JI, 1985
)
0.27
" To gather relevant data on pharmacokinetic characteristics of depot fluphenazines, the authors measured plasma levels of neuroleptic activity in 76 clinic patients on stable dosage regimens of fluphenazine decanoate or fluphenazine enanthate."( Plasma levels of neuroleptic in patients receiving depot fluphenazine.
Chouinard, G; Cohen, BM; Jones, B; Sommer, BR; Waternaux, C, 1985
)
0.27
"In 14 schizophrenic patients, prolactin levels are studied in relation to dosage of depot fluphenazine and gender of patient."( Depot fluphenazine and plasma prolactin.
Gift, T; Plum, K; Price, M, 1985
)
0.27
" The evidence available from prospective controlled trials suggests that substantial dosage reduction is feasible for a subgroup of outpatient schizophrenics and that the incidence of abnormal involuntary movements might be reduced by such a strategy."( Low dose medication strategies in the maintenance treatment of schizophrenia.
Kane, JM, 1983
)
0.27
" The clinical significance of plasma monitoring of depot fluphenazine, including the development of dosage conversion guidelines, is presented."( Future of depot neuroleptic therapy: pharmacokinetic and pharmacodynamic approaches.
Davis, CM; Ereshefsky, L; Jann, MW; Richards, A; Saklad, SR; Seidel, DR, 1984
)
0.27
" Maximum concentrations appeared at 1 week after administration of cis(Z)-clopenthixol decanoate, whereas the highest concentrations after fluphenazine decanoate were seen at the end of the 3-week dosage interval."( Blood and plasma kinetics of cis(Z)-clopenthixol and fluphenazine in psychiatric patients after intramuscular injection of their decanoic esters.
Ba, B; Berda, C; D'Agostino, N; Dufour, H; Durand, A; Hou, N; Jørgensen, A; Viala, A, 1984
)
0.27
"In an attempt to begin to establish minimum effective dosage requirements for the maintenance treatment of schizophrenia, we undertook a double-blind comparison of low-dose fluphenazine decanoate (1."( Low-dose neuroleptic treatment of outpatient schizophrenics. I. Preliminary results for relapse rates.
Kane, JM; Ramos-Lorenzi, J; Reardon, G; Rifkin, A; Sarantakos, S; Schiebel, D; Woerner, M, 1983
)
0.27
"5 mg/kg) for a variable period of time (4 to 28 days), depending upon the dosage of the neuroleptic used (2."( Effects of fluphenazine decanoate (a long-acting phenothiazine) on serum prolactin and amphetamine-induced behavioural changes.
Merali, Z; Toth, G, 1982
)
0.26
"281 newly admitted female schizophrenic patients were treated with high dosage fluphenazine decanoate intramuscularly, starting with 250 mg per injection together with antiparkinsonian and antidepressant drugs."( Follow-up study of 281 schizophrenic patients treated with high dosage fluphenazine decanoate.
Nagy, C; Steiner, S, 1981
)
0.26
" In addition, the clinician should consider the dosage schedule of each medication and balance this against the probability of extrapyramidal side effects and noncompliance."( Dose response of prophylactic antipsychotics.
Brauzer, B; Casey, DE; Davis, JM; Gierl, B; Hassan, M; Kane, JM; Marder, SR; Schooler, N, 1993
)
0.29
" Dosage data from the first 208 successfully-stabilized TSS subjects were examined."( Stabilization and depot neuroleptic dosages.
Lee, JH; Schooler, NR; Schulz, SC; Severe, JB; Weiden, P, 1993
)
0.29
"This study examined substance use among a group of 37 schizophrenia patients participating in a year-long fluphenazine decanoate (FD; Prolixin) dosage reduction study (Inderbitzin et al."( Substance use: a powerful predictor of relapse in schizophrenia.
Inderbitzin, LB; Kasckow, JW; Scheller-Gilkey, G; Swofford, CD, 1996
)
0.29
" The aim of the study was to find out whether age at onset of schizophrenia is related to the dosage of typical neuroleptics in outpatients."( Age at onset of schizophrenia and neuroleptic dosage.
Dernovsek, MZ; Tavcar, R, 1999
)
0.3
" Neuroleptic dosage was converted to milligrams of chlorpromazine equivalents and logarithmically transformed to obtain normal distribution."( Age at onset of schizophrenia and neuroleptic dosage.
Dernovsek, MZ; Tavcar, R, 1999
)
0.3
" The average dosage was 251."( Age at onset of schizophrenia and neuroleptic dosage.
Dernovsek, MZ; Tavcar, R, 1999
)
0.3
" Therapeutic monitoring of antipsychotic plasma levels has the potential for helping clinicians in dosage selection."( Fluphenazine plasma level monitoring for patients receiving fluphenazine decanoate.
Aravagiri, M; Lebell, M; Marder, SR; Mintz, J; Wirshing, DA; Wirshing, WC, 2002
)
0.31
"9% of the total antipsychotic dosage on average."( Ten year outcomes of outpatients with schizophrenia on conventional depot antipsychotics: a systematic chart review.
Den, R; Mimura, M; Sakurai, H; Suzuki, T; Tsutsumi, C; Uchida, H; Uchida, T, 2013
)
0.39
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
phenothiazine antipsychotic drugnull
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
dopaminergic antagonistA drug that binds to but does not activate dopamine receptors, thereby blocking the actions of dopamine or exogenous agonists.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
phenothiazines
decanoate esterA fatty acid ester resulting from the formal condensation of the carboxy group of decanoic acid (capric acid) with the hydroxy group of an alcohol or phenol.
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
N-alkylpiperazine
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (1)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency14.12540.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (8)

Assay IDTitleYearJournalArticle
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1135106Antipsychotic activity in albino rat assessed as duration of inhibition of conditioned avoidance behavior at 25 mg/kg administered intramuscularly1977Journal of medicinal chemistry, Feb, Volume: 20, Issue:2
Esters of 4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazieneethanol and related compounds as long-acting antipsychotic agents. Synthesis of the 1-adamantoate, the first crystalline base.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (303)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990191 (63.04)18.7374
1990's74 (24.42)18.2507
2000's24 (7.92)29.6817
2010's12 (3.96)24.3611
2020's2 (0.66)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 25.00

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index25.00 (24.57)
Research Supply Index6.00 (2.92)
Research Growth Index4.15 (4.65)
Search Engine Demand Index30.30 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (25.00)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials78 (23.93%)5.53%
Reviews14 (4.29%)6.00%
Case Studies59 (18.10%)4.05%
Observational0 (0.00%)0.25%
Other175 (53.68%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (10)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial [NCT02307396]Phase 421 participants (Actual)Interventional2015-02-01Completed
Ascending-Dose, Double-Blind, Placebo-Controlled, Bilateral Study of Intralesional Fluphenazine Decanoate in Psoriasis [NCT00356200]Phase 210 participants (Actual)Interventional2006-07-31Terminated(stopped due to Enrollment criteria met)
Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma [NCT00821301]Phase 130 participants (Anticipated)Interventional2008-12-31Recruiting
A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic [NCT02600741]296 participants (Actual)Observational2015-07-24Completed
A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma [NCT00335647]Phase 1/Phase 230 participants (Anticipated)Interventional2006-01-31Completed
[NCT00161018]Phase 3150 participants Interventional2003-11-30Completed
Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial) [NCT00014001]Phase 41,600 participants Interventional2000-12-31Completed
Comparative Effects of a D2 and Mixed D1-D2 Dopamine Antagonist on Gambling and Amphetamine Reinforcement in Pathological Gamblers and Healthy Controls [NCT02203786]Phase 260 participants (Actual)Interventional2009-09-30Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis [NCT00929578]Phase 215 participants (Actual)Interventional2008-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00356200 (2) [back to overview]Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.
NCT00356200 (2) [back to overview]Change in Target Lesion Score at Week 4 Compared to Baseline
NCT00929578 (4) [back to overview]Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks
NCT00929578 (4) [back to overview]Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks
NCT00929578 (4) [back to overview]Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.
NCT00929578 (4) [back to overview]Safety Outcome Measures
NCT02203786 (6) [back to overview]Betting Behaviour in Laboratory-based Slot Machine Game
NCT02203786 (6) [back to overview]Cognitive Task Performance
NCT02203786 (6) [back to overview]Diastolic Blood Pressure (DBP)
NCT02203786 (6) [back to overview]Speed of Play on Slot Machine Game
NCT02203786 (6) [back to overview]Subjective Reinforcement Self-report Scales
NCT02203786 (6) [back to overview]Winnings on Slot Machine Upon Completion of Game

Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.

Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis). (NCT00356200)
Timeframe: Baseline to week 4

Interventionmm (Mean)
Cohort 1, 10 ug/ml Fluphenazine Treated Lesion-30
Cohort 1, Placebo Treated Lesion-27.2
Cohort 2, 100 ug/ml Fluphenazine Treated Lesion-18
Cohort 2, Placebo Treated Lesion-32.6

[back to top]

Change in Target Lesion Score at Week 4 Compared to Baseline

Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity). (NCT00356200)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
Cohort 1, 10 ug/ml Fluphenazine Treated Lesion-1
Cohort 1, Placebo Treated Lesion-0.8
Cohort 2, 100 ug/ml Fluphenazine Treated Lesion-0.4
Cohort 2, Placebo Treated Lesion-1.5

[back to top]

Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks

Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores. (NCT00929578)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Placebo-1.4
Fluphenazine-1.4

[back to top]

Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks

Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive. (NCT00929578)
Timeframe: 4 weeks

Interventionpercentage of baseline pruritus (Mean)
Placebo0.86
Fluphenazine-2.16

[back to top]

Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.

Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose. (NCT00929578)
Timeframe: 1 week

Interventionparticipants (Number)
Baseline0
2 Hours Post Dose2
1 Week Post Dose2

[back to top]

Safety Outcome Measures

adverse events will be recorded and monitored. Adverse events will be noted in a separate chart. (NCT00929578)
Timeframe: 8 weeks

InterventionAll Study Participant (Number)
All Study Participants12

[back to top]

Betting Behaviour in Laboratory-based Slot Machine Game

Risk taking was operationally defined as credits wagered per spin (mean computed for total spins) (NCT02203786)
Timeframe: 1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)

,,,
Interventioncredits/spin on slot machine (Mean)
Mean bet under drugMean bet under placebo
Fluphenazine - Controls14.412.2
Fluphenazine - Pathological Gamblers16.016.1
Haloperidol - Controls11.69.5
Haloperidol - Pathological Gamblers12.810.4

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Cognitive Task Performance

Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience) (NCT02203786)
Timeframe: At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)

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Interventionpercentage of neutral categorized words (Mean)
post-slots-GAM words under drugpost-slots-ALC words under drugpost-slots POS words under drugpost-slots NEG words under drugpost-slots GAM words under placebopost-slots ALC words under placebopost-slots POS words under placebopost-slots NEG words under placebopeak AMPH GAM words under drugpeak AMPH ALC words under drugpeak AMPH POS words under drugpeak AMPH NEG words under drugpeak AMPH GAM words under placebopeak AMPH ALC words under placebopeak AMPH POS words under placebopeak AMPH NEG words under placebo
Fluphenazine - Controls91.093.188.387.992.193.386.884.797.0100.396.398.796.997.595.196.7
Fluphenazine - Pathological Gamblers94.098.195.396.595.099.094.997.295.899.598.799.497.999.997.7100.0
Haloperidol - Controls94.896.593.789.697.297.093.792.398.199.197.296.896.8100.297.898.1
Haloperidol - Pathological Gamblers91.695.591.389.191.694.892.793.096.7101.298.299.595.099.998.499.0

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Diastolic Blood Pressure (DBP)

Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine. (NCT02203786)
Timeframe: At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).

,,,
Interventionmm Hg (Mean)
Drug-Change in DBP pre-to-post slot machinePlacebo-Change in DBP pre-to-post slot machineDrug-Change in DBP pre-amphetamine to peak amphPlacebo-Change in DBP pre-amphetamine to peak amp
Fluphenazine - Controls23.61932.736.3
Fluphenazine - Pathological Gamblers2221.632.135.2
Haloperidol - Controls15.119.128.526.6
Haloperidol - Pathological Gamblers20.222.527.233.6

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Speed of Play on Slot Machine Game

Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager. (NCT02203786)
Timeframe: 15-minutes

,,,
Interventionindividual spins/15-minutes (Mean)
Spins/15-minutes under DrugSpins/15-minutes under Placebo
Fluphenazine - Controls71.866.7
Fluphenazine - Pathological Gamblers78.568.4
Haloperidol - Controls66.472.2
Haloperidol - Pathological Gamblers76.988.6

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Subjective Reinforcement Self-report Scales

Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group. (NCT02203786)
Timeframe: At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).

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Interventionunits on a scale (Mean)
Drug - Confidence not to gamble after slot machinePlacebo - Confidence not to gamble after slot machDrug - Confidence not to gamble at peak amphetaminPlac -Confidence not to gamble at peak amphetamine
Fluphenazine - Controls9.38.29.89.3
Fluphenazine - Pathological Gamblers4.84.86.45.7
Haloperidol - Controls9.599.89.4
Haloperidol - Pathological Gamblers4.84.25.25.5

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Winnings on Slot Machine Upon Completion of Game

Credits (NCT02203786)
Timeframe: 15-minutes

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Interventioncredits (Mean)
Winnings (Final Credit Tally) under drugWinnings (Final Credit Tally) under Placebo
Fluphenazine - Controls544.3215
Fluphenazine - Pathological Gamblers277.8140.8
Haloperidol - Controls449.1339.2
Haloperidol - Pathological Gamblers239562.4

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