Effect of drug Cariprazine on Impulsivity and Emotional dysregulation among Patients of Bipolar Disorder with Cluster B Personality.

Effect of Cariprazine on Impulsivity and Emotional Dysregulation among Patients with Bipolar Affective Disorder with Cluster B Personality traits - an Open Label fNIRS Study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056347

Enrollment

Registered

2023-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity Health Condition 2: F315- Bipolar disorder, current episodedepressed, severe, with psychotic features Health Condition 3: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features Health Condition 4: F310- Bipolar disorder, current episodehypomanic Health Condition 5: F312- Bipolar disorder, current episodemanic severe with psychotic features Health Condition 6: F311- Bipola

Interventions

Intervention1: cariprazine treatment: cariprazine as antipsychotic with lithium carbonate as mood stabiliser (SLE: 0.8-1.2) in patients of bipolar affective disorder with cluster b personality traits.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients falling under ICD 11 DCR criteria for Bipolar Affective Disorder Patients with Cluster B Personality traits. 2. Age group between 18-60 years of age of either sex. 3. Patients giving written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. Significant medical or neurological illness. 3. Comorbid substance use in dependence pattern other than caffeine and nicotine. 4. Actively suicidal (beck suicidal intent scale > 29)

Design outcomes

Primary

Measure	Time frame
To investigate the efficacy of Cariprazine in decreasing impulsivity & emotional dysregulation among patients with Bipolar Affective Disorder with Cluster B Personality traits.Timepoint: baseline, 2nd week, 4th week, 6th week	—

Secondary

Measure	Time frame
To assess the relationship among emotional dysregulation & impulsivity and resting state functional connectivity of prefrontal cortex using fNIRS in Patients with Bipolar Affective Disorder with Cluster B Personality traits before treatment. To compare the resting state functional connectivity of prefrontal cortex using fNIRS in patients receiving Cariprazine before and after treatment. To assess the improvement in suicidality & affective symptoms among Patients with Bipolar Affective Disorder with Cluster B Personality traits with Cariprazine. To study the correlation of improvement in the severity of symptoms of Patients with Bipolar Affective Disorder with Cluster B Personality traits with sociodemographic, clinical and fNIRS resting state functional connectivity in patients receiving Cariprazine. Timepoint: baseline, 2nd week, 4th week, 6th week	—

Measure

Time frame

To assess the relationship among emotional dysregulation & impulsivity and resting state functional connectivity of prefrontal cortex using fNIRS in Patients with Bipolar Affective Disorder with Cluster B Personality traits before treatment. To compare the resting state functional connectivity of prefrontal cortex using fNIRS in patients receiving Cariprazine before and after treatment. To assess the improvement in suicidality & affective symptoms among Patients with Bipolar Affective Disorder with Cluster B Personality traits with Cariprazine. To study the correlation of improvement in the severity of symptoms of Patients with Bipolar Affective Disorder with Cluster B Personality traits with sociodemographic, clinical and fNIRS resting state functional connectivity in patients receiving Cariprazine. Timepoint: baseline, 2nd week, 4th week, 6th week

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Countries

India

Contacts

Public ContactDr Surjit prasad

Central institute of psychiatry Ranchi

surjitbhaimbbs@gmail.com8051213044

Outcome results

None listed

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