CHLORPROMAZINE SUMMARY
Chlorpromazine HCl Injection, USP
Rx only
Chlorpromazine HCl is chemically designated as 2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine monohydrochloride and has the following structural formula.
Chlorpromazine (chlorpromazine) is indicated for the following:
For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.
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NEWS HIGHLIGHTS
Published Studies Related to Chlorpromazine
Levomepromazine versus chlorpromazine in treatment-resistant schizophrenia: a double-blind randomized trial. [2006.07]
OBJECTIVE: We compared the effect of levomepromazine (LMP) with chlorpromazine (CPZ) in treatment-resistant schizophrenia (TRS)... CONCLUSION: LMP and CPZ may be useful in the management of TRS. A modest advantage of LMP compared with CPZ was seen in longitudinal analysis. High doses of neuroleptics may contribute to TRS; reduction of neuroleptics to modest or moderate doses should be considered before categorizing a patient as treatment resistant.
Clotiapine compared with chlorpromazine in chronic schizophrenia. [2005.12.15]
OBJECTIVES: Clotiapine is a classic neuroleptic with a chemical structure similar to clozapine. It was said that patients unresponsive to other neuroleptics respond to clotiapine although it causes extrapyramidal syndromes (EPS) like other typical neuroleptics. We conducted a study of clotiapine vs. chlorpromazine in severe chronic active psychotic hospitalized schizophrenia patients... CONCLUSION: Some classic neuroleptic compounds may have superiority to chlorpromazine in a "clozapine-like" manner, despite a typical profile for EPS.
Clinical Trials Related to Chlorpromazine
Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia [Terminated]
This study will examine the physical response to clozapine or chlorpromazine in people with
schizophrenia that has not improved with treatment.
Comparison of Combination Olanzapine+Lithium or Chlorpromazine+Lithium in Treatment of First Manic Episode With Psychotic Features [Recruiting]
Aim: In a population of first episode manic patients with psychotic features, we want to
compare the side effect profile, the degree of adherence and the subjective well being, as
well as the efficacy of two treatments: The standard treatment currently applied (lithium +
chlorpromazine) and an alternative treatment more recently introduced (lithium +
olanzapine). In addition, we want to study retrospectively the development of bipolar
disorder and study prospectively the 6 and 12-month outcome of a cohort of patients
presenting a first manic episode with psychotic features.
Research Background: While the efficacy of lithium in the treatment of acute mania has been
established by numerous studies, it is also known that up to 50% of the patients fail to
respond when it is prescribed alone. It is therefore common practice to complement the
treatment, most commonly with antipsychotics and benzodiazepines. It has been suggested that
antipsychotic agents are faster acting and are superior in controlling hyperactivity
compared to lithium, whereas mood stabilisation is better achieved by lithium, Typical
antipsychotics, such as chlorpromazine, may therefore be useful as adjunctive medication to
mood stabilisers, especially within the first few weeks of treatment of acute mania, and for
patients exhibiting psychotic symptoms or hyperactivity. They however can induce side
effects (somnolence, dizziness, dry mouth, extrapyramidal side effects such as rigidity of
the muscles, and possibly tardive dyskinesia (involuntary movements or contraction of
muscles), as well as akathysia (sense of restlessness). They finally have been suspected to
contribute to the occurrence of post-manic depression. Recent publications in chronic
populations have shown that atypical antipsychotics, such as olanzapine, are also an
effective adjunctive treatment. Olanzapine has the important advantage to induce a very low
incidence of extrapyramidal side effects, including tardive dyskinesia. It can however
induce somnolence, dizziness, dry mouth, and rather commonly weight gain. Moreover, some
authors have reported that olanzapine might induce mania. Both treatments appear then to
have positive effects as well as undesirable side effects. Our project is to compare them.
The literature concerning first episode mania is sparse, particularly in the domain of
pharmacotherapy. One retrospective study showed that 77% of the patients received
antipsychotics at discharge and 25% at 6 months follow-up. No comparison has however been
made between typical and atypical antipsychotics, and there are no specific treatment
guidelines of first episode mania with psychotic features.
Project Summary: The hypothesis is that olanzapine and chlorpromazine will have a comparable
efficacy as adjunctive treatment of the acute manic episode with psychotic features. We
however think olanzapine will induce less side effects and will be better accepted by the
patients, and therefore that the adherence to the treatment will be better than with
chlorpromazine. We finally think the subjective sense of well being will be greater with
olanzapine than with chlorpromazine. We will recruit 75 patients at the time of their first
admission for mania with psychotic features at EPPIC. After signature of the informed
consent, we will perform a baseline assessment first to confirm the diagnosis, and second to
evaluate the level of psychopathology. The patients will then be randomly selected to
receive either a treatment of lithium and olanzapine or a treatment of lithium and
chlorpromazine. By the end of the study there will be 37 patients in each group. The patients
will go through a baseline assessment including physical examination and usual laboratory
investigation to exclude any physical illness. They will also go through a one-hour
assessment of psychopathology. Between day 2 and 3 they will go through 2 hours of interview
to reassess diagnosis and personal history. They will thereafter be assessed weekly for
eight weeks on various dimensions: evolution of the intensity of the symptoms, appearance of
depressive symptoms, occurrence of side effects and degree of adherence to the treatment, in
an 1-hour interview. Subjective well being and quality of life will re evaluated at week 4
and 8, adding 45 minutes to the duration of the interview. This is a flexible dose, open
trial, which means the doctor in charge of the patient will know which medication is being
prescribed, and that he will be allowed to adapt the dosage according to what he feels
necessary. This research project will allow us to organise a more specialised clinic for the
care of first episode manic patients. We will take this opportunity to study carefully the
months preceding the appearance of the first episode in order to try to reconstruct the
prodrome of bipolar disorders. We will also, in an extension phase of the study, look at the
long term outcome (at 6 and 12 months) of a first episode of mania.
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients [Recruiting]
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate
extended-release (XR) used as mono-therapy, administered once daily, in the treatment of
schizophrenic patient with acute episode.
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia [Completed]
Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high
discontinue rate. To solve these problems, we provide practical and available psychosocial
intervention. We hypothesize that there will be significant difference in the overall
effectiveness between antipsychotic and antipsychotic combination with psychosocial
intervention.
An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue [Recruiting]
Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the
treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder
called modafinil (ProvigilTM). There is considerable off label evidence for modafinil's
ability to reduce fatigue related to multiple sclerosis, Parkinson's disease, cancer related
fatigue, and depression related fatigue. There are preclinical studies showing that
modafinil can alleviate fatigue secondary to medication side effects (diazepam,
chlorpromazine). This multi-layered evidence base suggests that modafinil may be able to
alleviate fatigue regardless of medical illness. Armodafinil now has four completed Phase
III FDA regulatory studies revealing that it is well tolerated and effective for fatigue
associated with obstructive sleep apnea (Effects of Armodafinil in the Treatment of Residual
Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome: A 12-Week,
Multicenter, Double-Blind, Randomized,Placebo-Controlled Study in nCPAP-Adherent Adults.
Thomas Roth et al. Clinical Therapeutics/Volume 28, Number 5, 2006), shift work sleep
disorder, and narcolepsy. Armodafinil is not yet FDA approved. It is felt to be a
cleaner, safer, more potent isomer. Theoretically, fatigue is interpreted and possibly
dictated centrally and armodafinil's proposed mechanism (similar to that of modafinil) of
elevating central histamine activity may allow the brain to interpret a lower fatigue state,
thus allowing patients to function better during the day with less peripheral fatigue.
Fibromyalgia (FM) is an illness that may involve medical, rheumatological, autoimmune,
sleep, endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger
points. Greater than 90% of these patients will report fatigue as a key symptom as well.
There are several investigation lines into the treatment of FM induced pain. Exercise,
behavioral therapy, amitryptiline, duloxetine, tramadol, sodium oxybate all have randomized
trials and almost all focus on pain. There are very few studies, if any, that look at FM
induced fatigue which certainly ads to FM patients' daily incapacity and lowered
productivity/quality of life.
Armodafinil is a drug with minimal adverse effects (headache, insomnia, GI distress,
anxiety, dry mouth, dizziness and an assumed low level addiction which is comparable to
modafinil) which is well tolerated in current regulatory studies. It may have a safer
tolerability profile than the FM medications noted above. As modafinil is often studied and
often added as an augmentation agent to patients' regimens who suffer from fatigue in other
medical illnesses, the authors feel that armodafinil would also be effective in this
population. The authors wish to conduct a study to determine if armodafinil is safe and
tolerable in the treatment of FM induced fatigue. This initial controlled study may allow
for continued regulatory studies with this product in FM subjects. We propose a
double-blind placebo controlled study to determine if armodafinil is safe and effective in
reversing FM induced fatigue.
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Page last updated: 2006-11-04
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