AnxietyPhase 1RAKGEOCBTNCT06993662

The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.

A Phase 1 study testing Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression., Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD and Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. in people with Anxiety and Depression, run by Rakitzi, Stavroula at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anxiety, Depression, Obsessive-compulsive Disorder
What is being tested?: Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression., Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD and Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 1 siteGreece
Study dates: 2 Jun 2025to 3 Aug 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18-65,
IQ ≥ 80,
Diagnosis: anxiety disorders, depression, obsessive-compulsive disorders, PTSD, personality disorders, bipolar disorders, schizophrenia and psychotic disorders.

Who cannot join

Substance abuse and head injury.

Trial locations and contacts

1 site in 1 country.

Greece1 site

Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE
Athens, 15771

Other trials in Greece

About this study

Official title: The Effectiveness and Efficacy of the Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective for Patients With Mental Health Disorders

The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.

Read the detailed description

Reintegration into society and good functional outcome by people with mental health disorders is frequently the result of the combination of pharmacotherapy and individual cognitive behavioral psychotherapy. The effectiveness and efficacy of this combination of treatments under the recovery perspective by anxiety disorders, depressive disorders, PTSD, bipolar disorders, schizophrenia and psychotic disorders, by obsessive-compulsive disorders and by personality disorders presents the main goal of this research protocol. Recovery means that people learn through the trherapy to be responsible towards their own problems.

Conditions: Anxiety, Depression, Obsessive-compulsive Disorder, Personality Disorder, Bipolar Disorder, Schizophrenia
Being tested: Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression., Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD, Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder., Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder, Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders
Keywords: Pharmacotherapy, Cognitive behavioral psychotherapy, Recovery
Medical subject headings: Anxiety Disorders, Depression, Obsessive-Compulsive Disorder, Personality Disorders, Bipolar Disorder, Schizophrenia, Psychotic Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.Combination product
The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.
Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSDCombination product
The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by PTSD
Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.Combination product
The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.
Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorderCombination product
The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil) antidepressants (SSRI, SNRI), mood stabilizers (lithium, depakine), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorder.
Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disordersCombination product
The combination of pharmacotherapy (anxiolytics(tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders.
Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disordersCombination product
The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics) and individual cognitive behavioral psychotherapy by personality disorders.

Study groups in NCT06993662
Study group	Role	What they receive
Group A	Experimental	The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by anxiety disorders and depression. 20 patients Receives: Combination Product: Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.
Group B	Experimental	The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD. 12 patients Receives: Combination Product: Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD
Group C	Experimental	The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. 15 patients Receives: Combination Product: Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.
Group D	Experimental	The combination of pharmacotherapy (anxiolytics ((Tavor, clonotril, lexotanil), antidperessants (SSRI, SNRI), mood stabilizers (Lithium, depakine) and antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorders. 15 patients Receives: Combination Product: Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder
Group E	Experimental	The combination of pharmacotherapy (antipsychotics (clozapine and atypical antipsychotics)) , anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders. 20 patients Receives: Combination Product: Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders
Group F	Experimental	The combination of pharmacotherapy (antidepressants (SSRI, SNRI), anxiolytics (Tavor, clonotril, lexotanil) antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by personality disorders. 20 patients (2 narcistic personality disorder, 5 borderline personality disorder, 4 obsessive-compulsive disorder, 5 avoidant personality disorder, 4 depedent personality disorder) Receives: Combination Product: Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

MCCB BACS symbol coding
It measures speed of processing. Minimum 0, maximum 110, high scores better
Measured: Preintervention
MCCB BACS symbol coding
It measures speed of processing. Minimum 0, maximum 110, high scores better
Measured: Immediately after the intervention
MCCB BACS symbol coding
It measures speed of processing. Minimum 0, maximum 110, high scores better
Measured: Follow-up up to 24 weeks
MCCB Wechsler memory scale-spatial span
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
Measured: Preintervention
MCCB Wechsler memory scale-spatial span
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
Measured: Immediately after the intervention
MCCB Wechsler memory scale-spatial span
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
Measured: Follow-up up to 24 weeks
MCCB Neurospychological Assessment Battery (NAB)
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
Measured: Preintervention
MCCB Neurospychological Assessment Battery (NAB)
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
Measured: Immediately after the intervention
MCCB Neurospychological Assessment Battery (NAB)
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
Measured: Follow-up up to 24 weeks
MCCB Brief visuospatial memory test
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
Measured: Preintervention
MCCB Brief visuospatial memory test
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
Measured: Immediately after the intervention
MCCB Brief visuospatial memory test
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
Measured: Follow-up up to 24 weeks
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
Measured: Preintervention
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
Measured: Immediately after the intervention
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
Measured: Follow-up up to 24 weeks
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Preintervention
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Immediately after the intervention
The Greek verbal memory test
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Follow-up up to 24 weeks
The Greek verbal memory test
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Preintervention
The Greek verbal memory test
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Immediately after the intervention
The Greek verbal memory test
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
Measured: Follow-up up to 24 weeks
The Greek verbal memory test
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
Measured: Preintervention
The Greek verbal memory test
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
Measured: Immediately after the intervention
The Greek verbal memory test
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
Measured: Follow-up up to 24 weeks
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Preintervention
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Immediately after the intervention
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Follow-up up to 24 weeks
PANNS total
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
Measured: Preintervention
PANNS total
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
Measured: Immediately after the intervention
PANNS total
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
Measured: Follow-up up to 24 weeks
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Preintervention
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Immediately after the intervention
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Follow-up up to 24 weeks
RAS-DS total
It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Preintervention
RAS-DS total
It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Immediately after the intervention
RAS-DS total
It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Follow-up up to 24 weeks
The Clinical Global Impression Scale (CGI)
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
Measured: Preintervention
The Clinical Global Impression Scale (CGI)
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
Measured: Immediately after the intervention
The Clinical Global Impression Scale (CGI)
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
Measured: Follow-up up to 24 weeks
The Clinical Global Impression Scale (CGI)
It measures global improvement. Minimum 0, Maximum 7, low scores better.
Measured: Preintervention
The Clinical Global Impression Scale (CGI)
It measures global improvement. Minimum 0, Maximum 7, low scores better.
Measured: Immediately after the intervention
The Clinical Global Impression Scale (CGI)
It measures global improvement. Minimum 0, Maximum 7, low scores better.
Measured: Follow-up up to 24 weeks
SRSDA
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
Measured: Preintervention
SRSDA
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
Measured: Immediately after the intervention
SRSDA
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
Measured: Follow-up up to 24 weeks
SRSDA B
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Measured: Preintervention
SRSDA B
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Measured: Immediately after the intervention
SRSDA B
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Measured: Follow-up up to 24 weeks
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Preintervention
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Immediately after the intervention
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Follow-up up to 24 weeks
Montgomery and Asperg depression scale
It measures depression. Minimum 0, maximum 60. Low scores better.
Measured: Preintervention
Montgomery and Asperg depression scale
It measures depression. Minimum 0, maximum 60. Low scores better.
Measured: Immediately after the intervention
Montgomery and Asperg depression scale
It measures depression. Minimum 0, maximum 60. Low scores better.
Measured: Follow-up up to 24 weeks
The Altman self-rating scale
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
Measured: Preintervention
The Altman self-rating scale
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
Measured: Immediately after the intervention
The Altman self-rating scale
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
Measured: Follow-up up to 24 weeks
The Young mania rating scale
It measures mania. Minimum 0, maximum 60. Low scores better
Measured: Preintervention
The Young mania rating scale
It measures mania. Minimum 0, maximum 60. Low scores better
Measured: Immediately after the intervention
The Young mania rating scale
It measures mania. Minimum 0, maximum 60. Low scores better
Measured: Follow-up up to 24 weeks
PSYRAT H
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
Measured: Preintervention
PSYRAT H
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
Measured: Immediately after the intervention
PSYRAT H
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
Measured: Follow-up up to 24 weeks
PSYRAT D
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
Measured: Preintervention
PSYRAT D
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
Measured: Immediately after the intervention
PSYRAT D
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
Measured: Follow-up up to 24 weeks

Secondary outcomes (1)

WAIS
It measures the Intelligenz-quotient. For bipolar disorder, schizophrenia and psychotic disorders
Measured: Preintervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 20253 Aug 2026

First posted29 May 2025
Study start2 Jun 2025
Primary completion3 Aug 2026
Study completion3 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06993662
Sponsor's protocol ID: RAKITZI & GEORGILA CBT
Acronym: RAKGEOCBT
Status last verified: Aug 2026
First submitted: 23 Apr 2025
Last updated: 4 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: This is our first effectiveness study regarding pharmacotherapy and cognitive behavioral psychotherapy in our private practice.

Publications

2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.
Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman Self-Rating Mania Scale. Biol Psychiatry. 1997 Nov 15;42(10):948-55. doi: 10.1016/S0006-3223(96)00548-3.
PubMed 9359982
Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405
Donias, S., Karastergiou, A., & Manos N. (1991). Standardization of the symptom checklist-90-R rating scale in a Greek population. Psychiatriki, 2(1), 42-48
Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21.
PubMed 14667249
Guy, W. (ed). (1976). ECDEU Assessment. Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976
Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
PubMed 10473315
Hancock, N., Scanlan, J.N., Bundy, A.C., Honey, A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.
Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version.
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518
.Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos.
Koumpouros, Y., Papageorgiou, E., & Sakellari E. et al. (2018). Adaptation and psychometric properties evaluation of the Greek version of WHODAS 2.0. Pilot application in Greek elderly population. Health Services and Outcomes Research Methodology, 18(1), 63-74. https://doi.org/10.1007/s10742-017- 0176-x
.Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: Scientific Publications
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness and Efficacy of the Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective for Patients With Mental Health Disorders
ClinicalTrials.gov ID: NCT06993662
Acronym / sponsor ID: RAKGEOCBT / RAKITZI & GEORGILA CBT
Conditions: Anxiety, Depression, Obsessive-compulsive Disorder, Personality Disorder, Bipolar Disorder, Schizophrenia
Keywords: Pharmacotherapy, Cognitive behavioral psychotherapy, Recovery
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Rakitzi, StavroulaUniversity, hospital or other
Study start: 2 Jun 2025 (actual)
Primary completion: 3 Aug 2026 (actual)
Study completion: 3 Aug 2026 (actual)
First posted: 29 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group A	Experimental	Combination Product: Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by anxiety disorders and depression. 20 patients
Group B	Experimental	Combination Product: Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSDThe combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD. 12 patients
Group C	Experimental	Combination Product: Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. 15 patients
Group D	Experimental	Combination Product: Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorderThe combination of pharmacotherapy (anxiolytics ((Tavor, clonotril, lexotanil), antidperessants (SSRI, SNRI), mood stabilizers (Lithium, depakine) and antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorders. 15 patients
Group E	Experimental	Combination Product: Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disordersThe combination of pharmacotherapy (antipsychotics (clozapine and atypical antipsychotics)) , anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders. 20 patients
Group F	Experimental	Combination Product: Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disordersThe combination of pharmacotherapy (antidepressants (SSRI, SNRI), anxiolytics (Tavor, clonotril, lexotanil) antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by personality disorders. 20 patients (2 narcistic personality disorder, 5 borderline personality disorder, 4 obsessive-compulsive disorder, 5 avoidant personality disorder, 4 depedent personality disorder)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age 18-65,
IQ ≥ 80,
Diagnosis: anxiety disorders, depression, obsessive-compulsive disorders, PTSD, personality disorders, bipolar disorders, schizophrenia and psychotic disorders.

Key exclusion criteria (1 listed)

Substance abuse and head injury.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.	Combination product	Group A
Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSDThe combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by PTSD	Combination product	Group B
Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.	Combination product	Group C
Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorderThe combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil) antidepressants (SSRI, SNRI), mood stabilizers (lithium, depakine), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorder.	Combination product	Group D
Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disordersThe combination of pharmacotherapy (anxiolytics(tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders.	Combination product	Group E
Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disordersThe combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics) and individual cognitive behavioral psychotherapy by personality disorders.	Combination product	Group F

Primary outcome

MCCB BACS symbol coding
Time frame: Preintervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB BACS symbol coding
Time frame: Immediately after the intervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB BACS symbol coding
Time frame: Follow-up up to 24 weeks
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB Wechsler memory scale-spatial span
Time frame: Preintervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Wechsler memory scale-spatial span
Time frame: Immediately after the intervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Wechsler memory scale-spatial span
Time frame: Follow-up up to 24 weeks
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Neurospychological Assessment Battery (NAB)
Time frame: Preintervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Neurospychological Assessment Battery (NAB)
Time frame: Immediately after the intervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Neurospychological Assessment Battery (NAB)
Time frame: Follow-up up to 24 weeks
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Brief visuospatial memory test
Time frame: Preintervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
MCCB Brief visuospatial memory test
Time frame: Immediately after the intervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
MCCB Brief visuospatial memory test
Time frame: Follow-up up to 24 weeks
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
The Greek verbal memory test
Time frame: Preintervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test
Time frame: Immediately after the intervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test
Time frame: Follow-up up to 24 weeks
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test
Time frame: Preintervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Immediately after the intervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Follow-up up to 24 weeks
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Preintervention
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Immediately after the intervention
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Follow-up up to 24 weeks
It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better
The Greek verbal memory test
Time frame: Preintervention
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
The Greek verbal memory test
Time frame: Immediately after the intervention
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
The Greek verbal memory test
Time frame: Follow-up up to 24 weeks
It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.
SCL-90-R
Time frame: Preintervention
It evaluates psychopathology. T>60 means psychopathology. Low scores better
SCL-90-R
Time frame: Immediately after the intervention
It evaluates psychopathology. T>60 means psychopathology. Low scores better
SCL-90-R
Time frame: Follow-up up to 24 weeks
It evaluates psychopathology. T>60 means psychopathology. Low scores better
PANNS total
Time frame: Preintervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
PANNS total
Time frame: Immediately after the intervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
PANNS total
Time frame: Follow-up up to 24 weeks
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total
Time frame: Preintervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
Time frame: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
Time frame: Follow-up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
Time frame: Preintervention
It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total
Time frame: Immediately after the intervention
It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total
Time frame: Follow-up up to 24 weeks
It measures recovery. Minimum 0, maximum 152. High scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Preintervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Immediately after the intervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Follow-up up to 24 weeks
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Preintervention
It measures global improvement. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Immediately after the intervention
It measures global improvement. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
Time frame: Follow-up up to 24 weeks
It measures global improvement. Minimum 0, Maximum 7, low scores better.
SRSDA
Time frame: Preintervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA
Time frame: Immediately after the intervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA
Time frame: Follow-up up to 24 weeks
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA B
Time frame: Preintervention
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
SRSDA B
Time frame: Immediately after the intervention
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
SRSDA B
Time frame: Follow-up up to 24 weeks
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Hamilton Depression Scale
Time frame: Preintervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
Time frame: Immediately after the intervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
Time frame: Follow-up up to 24 weeks
It measures depression. Minimum 0, maximum 23. Low scores better.
Montgomery and Asperg depression scale
Time frame: Preintervention
It measures depression. Minimum 0, maximum 60. Low scores better.
Montgomery and Asperg depression scale
Time frame: Immediately after the intervention
It measures depression. Minimum 0, maximum 60. Low scores better.
Montgomery and Asperg depression scale
Time frame: Follow-up up to 24 weeks
It measures depression. Minimum 0, maximum 60. Low scores better.
The Altman self-rating scale
Time frame: Preintervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Altman self-rating scale
Time frame: Immediately after the intervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Altman self-rating scale
Time frame: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Young mania rating scale
Time frame: Preintervention
It measures mania. Minimum 0, maximum 60. Low scores better
The Young mania rating scale
Time frame: Immediately after the intervention
It measures mania. Minimum 0, maximum 60. Low scores better
The Young mania rating scale
Time frame: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 60. Low scores better
PSYRAT H
Time frame: Preintervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT H
Time frame: Immediately after the intervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT H
Time frame: Follow-up up to 24 weeks
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT D
Time frame: Preintervention
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
PSYRAT D
Time frame: Immediately after the intervention
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
PSYRAT D
Time frame: Follow-up up to 24 weeks
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better

1 secondary outcome

WAIS
Time frame: Preintervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Background2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.
Background: PubMed 9359982Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman Self-Rating Mania Scale. Biol Psychiatry. 1997 Nov 15;42(10):948-55. doi: 10.1016/S0006-3223(96)00548-3.
BackgroundBech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.
Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
BackgroundDonias, S., Karastergiou, A., & Manos N. (1991). Standardization of the symptom checklist-90-R rating scale in a Greek population. Psychiatriki, 2(1), 42-48
Background: PubMed 14667249Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21.
BackgroundGuy, W. (ed). (1976). ECDEU Assessment. Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976
Background: PubMed 10473315Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
BackgroundHancock, N., Scanlan, J.N., Bundy, A.C., Honey, A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.
BackgroundHancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version.
Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
Background.Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos.
Individual participant dataSharing planned: No. This is our first effectiveness study regarding pharmacotherapy and cognitive behavioral psychotherapy in our private practice.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Stavroula Rakitzi, PhD study director

Private Practice

Dr. Polyxeni Georgila, M. D. study director

Private Practice

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCCB BACS symbol coding (time frame: Preintervention). The study lists 66 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06993662, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.