Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

Study Overview
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Brief Summary
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Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients. determine if after 12 months of treatment with clozapine, the BMI changes with clients who are councelled as usual regarding weight gain while on Clozapine. determine if after 12 months of treatment with clozapine, the BMI changes with intense, structured councelling about diet and exercise.

Detailed Description
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To determine whether the changes in BMI produced in subjects with Bipolar Disorder (BD) and Schizoaffective Disorder (SA) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.

Official Title
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Metabolic Side Effects, Diet and Exercise Counseling and Brain Function in a Naturalistic Clinical Trial of Clozapine for Treatment Resistant Bipolar and Schizoaffective Disorder

Conditions
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Bipolar Affective Disorder, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Counselling as Usual
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clients diagnosed with bipolar disorder or schizoaffective disorder Clients who respond poorly to treatment Males and females ages 18 years or older Clients who have had a trial of antipsychotics, incl. at least one atypical antipsychotic plus at least 2 mood stabilizers Clients who are capable of providing informed consent Exclusion Criteria: Clients who take carbamazepine Clients with a history of extremely low white blood counts Clients with severe kidney, liver or heart disease, or heart operation Clients are hypersensitive to clozapine Clients who have a history of serious side effects after previous treatment with clozapine Clients with alcohol or drugs abuse within the last 3 months Clients who have a seizure disorder Clients who have metal in the head, neck or eyes, shrapnel, bullets, or body piercing, a pacemaker, brain aneurism clips, cochlear implant, hearing aid, tens unit, spinal implant, or pregnancy. These safety measures are necessary because of the magnetic fields of the MRI scan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Counselling as Usual<br>Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes | Behavioral: Counselling as Usual<br>* 5 - 20 minutes, about the effects of clozapine on body weight, appetite, blood sugar and fats such as cholesterol and triglycerides in the blood, and how these might affect your health in the future.<br>|
| Cognitive Behavoural Therapy<br>Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes | Behavioral: CBT<br>* 45 - 60 minutes individual treatment sessions focused on nutrition, exercise and weight control and will occur weekly for 4 weeks. After this, 10 group sessions focused on weight reduction will be held every 2 weeks. This will be followed by 6 group sessions focused on weight maintenance held every 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increases in BMI in subjects with BD and SA after 12 months of clozapine treatment will be smaller in subjects treated with CBT ex/diet compared with those receiving CAU. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse changes in plasma lipids, blood sugar, and fitness level will be greater in subjects treated with CBT ex/diet compared with those receiving CAU after 12 months of clozapine treatment. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar and Schizoaffective Disorder, Clozapine, Metabolic Side Effects, Diet & Exercise, BMI