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Effect of Aripiprazole on Smoking Rate in Male Bipolar Mood Disorder I

Clinical trial Comparison of the effect of Aripiprazole and placebo on the rate of smoking in male patients with type I bipolar disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016121228173N3
Enrollment
40
Registered
2017-08-01
Start date
2017-01-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Mood Disorder, current episode manic without psychotic feauters. The patient is currently manic, without psychotic symptoms (as in F30.1), and has had at least one other affective episode (hypomanic, manic, depressive, or mixed) in the past.

Interventions

Intervention 1: Intervention group: Aripiprazole is administered at a dose of 10 mg per day for 6 weeks. Intervention 2: Control group: Placebo in terms of shape, size and weight similar to the ?Aripi
Treatment - Drugs
Placebo
Intervention group: Aripiprazole is administered at a dose of 10 mg per day for 6 weeks
Control group: Placebo in terms of shape, size and weight similar to the ?Aripiprazole drug for 6 weeks

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: The definitive diagnosis of bipolar I disorder according to DSM-IV-TR criteria; being in the partial or complete recovery phase based on Yang Mania Rating Scale; having the necessary criteria for diagnosis of nicotine dependence according to DSM-IV-TR criteria; age 18-60 Years old; male gender and consent to attend the study through the signing of informed consent. ?Exclusion Criteria: history of any allergic reaction to drug disorder with respect to Aripiprazole or other anti psychotics; dependence on other substances (based on the patient's history and the outcome of the test of morphine and methamphetamine at the start of the intervention); the use of other drugs used to quit nicotine; Use of medications other than bipolar disorder; history of physical illness (liver failure, renal failure); history of mental retardation; occurrence of any side effects due to Aripiprazole; history of cognitive impairment (dementia).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Smoking rate (nicotine). Timepoint: before intervention,Six weeks after the intervention. Method of measurement: Fagerstrom Test for Nicotine Dependence (FTQ).

Secondary

MeasureTime frame
Side effects of Aripiperazole. Timepoint: First and Fourth Week of Intervention. Method of measurement: Glasgow Antipsychotic Side-effect Scale (GASS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDR Mohammad Taher Taieb Zadegan

Razi Hospital

drtayebzadeganmt@yahoo.com+98 41 3380 4486

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026